Encore Medical recalls
Encore Medical appears in 99 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coa…
FDA Device · Class II · 2020-10-28 · Encore Medical
Reason: Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. - DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage:…
FDA Device · Class II · 2020-10-14 · Encore Medical
Reason: There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space. - RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
FDA Device · Class II · 2020-10-07 · Encore Medical
Reason: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; s… - RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
FDA Device · Class II · 2020-10-07 · Encore Medical
Reason: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; s… - EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The E…
FDA Device · Class II · 2020-05-20 · Encore Medical
Reason: The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space. - djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635
FDA Device · Class II · 2020-04-22 · Encore Medical
Reason: The retaining ring on the neck trials has a potential to fail interoperatively. - EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
FDA Device · Class II · 2019-12-18 · Encore Medical
Reason: The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off a… - Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P
FDA Device · Class II · 2019-08-07 · Encore Medical
Reason: Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a de… - Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00…
FDA Device · Class II · 2019-04-17 · Encore Medical
Reason: Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surg… - Foundation Modular Femoral Stem, Part Number, 220-10-110
FDA Device · Class II · 2018-09-12 · Encore Medical
Reason: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. - Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and t…
FDA Device · Class II · 2018-08-08 · Encore Medical
Reason: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible. - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the… - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the… - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the… - AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ins…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the… - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the… - EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. - DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. - EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. - EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. - Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use…
FDA Device · Class II · 2017-11-15 · Encore Medical
Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. - Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use…
FDA Device · Class II · 2017-11-15 · Encore Medical
Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. - Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cem…
FDA Device · Class II · 2017-11-15 · Encore Medical
Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. - Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cem…
FDA Device · Class II · 2017-11-15 · Encore Medical
Reason: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. - EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra…
FDA Device · Class II · 2017-11-01 · Encore Medical
Reason: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. - EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ul…
FDA Device · Class II · 2017-11-01 · Encore Medical
Reason: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. - MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, S…
FDA Device · Class II · 2017-09-06 · Encore Medical
Reason: It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended. - 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from u…
FDA Device · Class II · 2017-07-12 · Encore Medical
Reason: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. - 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from u…
FDA Device · Class II · 2017-07-12 · Encore Medical
Reason: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. - RSP Impaction Fixture
FDA Device · Class II · 2017-03-15 · Encore Medical
Reason: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. - Turon Impaction Fixture
FDA Device · Class II · 2017-03-15 · Encore Medical
Reason: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. - LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupl…
FDA Device · Class II · 2017-02-22 · Encore Medical
Reason: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma… - Empowr PS Knee Tibial Insert
FDA Device · Class II · 2017-02-15 · Encore Medical
Reason: The Empowr PS Insert was reported as missing the impaction slot feature. - Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabil…
FDA Device · Class II · 2016-12-21 · Encore Medical
Reason: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. - Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retai…
FDA Device · Class II · 2016-12-14 · Encore Medical
Reason: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. - Empowr PS Knee System Box Cut Guide
FDA Device · Class II · 2016-11-09 · Encore Medical
Reason: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can crea… - Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed f…
FDA Device · Class II · 2016-08-31 · Encore Medical
Reason: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics. - MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
FDA Device · Class II · 2016-07-27 · Encore Medical
Reason: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. - AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046
FDA Device · Class II · 2016-01-20 · Encore Medical
Reason: The trial shell mating feature on the broach is undersized. - Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replac…
FDA Device · Class II · 2015-11-04 · Encore Medical
Reason: The labeling is missing the size/diameter information. - Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on th…
FDA Device · Class II · 2015-11-04 · Encore Medical
Reason: During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. - Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to as…
FDA Device · Class II · 2015-11-04 · Encore Medical
Reason: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. - AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of s…
FDA Device · Class II · 2015-10-28 · Encore Medical
Reason: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. - FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
FDA Device · Class II · 2015-08-05 · Encore Medical
Reason: The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut bl… - 3DKnee e+ Tibial Insert
FDA Device · Class II · 2013-05-08 · Encore Medical
Reason: U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two f… - 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair
FDA Device · Class II · 2012-10-31 · Encore Medical
Reason: A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws la… - 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm
FDA Device · Class II · 2012-09-05 · Encore Medical
Reason: The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. - djo surgical Screw 6.5 mm, Sz 25mm, low profile
FDA Device · Class II · 2012-08-15 · Encore Medical
Reason: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25…