FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Device · Class II · 2020-11-18 · Merete Medical - END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems deve…
FDA Device · Class II · 2020-11-11 · Siemens Medical Solutions Usa - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thor…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a…
FDA Device · Class II · 2020-11-11 · Genicon - TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and main…
FDA Device · Class II · 2020-11-11 · Gordian Surgical - END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - Flow Sensor Service Part, Catalog 2096513-001-S
FDA Device · Class II · 2020-11-11 · Ge Healthcare - 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 elec…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Device · Class II · 2020-11-11 · Primus - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thor…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular syste…
FDA Device · Class II · 2020-11-11 · Angiodynamics - STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic a…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 elec…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business - GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to…
FDA Device · Class II · 2020-11-11 · Ge Healthcare - 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
FDA Device · Class II · 2020-11-11 · Origen Biomedical - SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, tho…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65…
FDA Device · Class II · 2020-11-11 · Rti Surgical Dba Pioneer Surgical Technology - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-28
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm Number: 00-8065-948-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 el…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the con…
FDA Device · Class II · 2020-11-11 · Ge Healthcare - 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only
FDA Device · Class II · 2020-11-11 · Ge Healthcare - Flow Sensor Service Part, Catalog 2089610-001-S
FDA Device · Class II · 2020-11-11 · Ge Healthcare - END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business - STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic a…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517
FDA Device · Class I · 2020-11-11 · Cook - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
FDA Device · Class II · 2020-11-11 · Boston Scientific - Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-M…
FDA Device · Class II · 2020-11-11 · Rti Surgical Dba Pioneer Surgical Technology - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cer…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm Number: 00-8065-954-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoraci…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-28
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of m…
FDA Device · Class II · 2020-11-11 · Cardinal Health 200 - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoraci…
FDA Device · Class III · 2020-11-11 · Synthes Usa Products
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