Stryker Howmedica Osteonics recalls
Stryker Howmedica Osteonics appears in 87 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.
- LFT v40 Femoral Head
FDA Device · Class II · 2015-03-11 · Stryker Howmedica Osteonics
Reason: Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem… - Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty proc…
FDA Device · Class II · 2015-02-11 · Stryker Howmedica Osteonics
Reason: Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. - Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13
FDA Device · Class II · 2014-10-22 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. - Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of…
FDA Device · Class II · 2014-07-09 · Stryker Howmedica Osteonics
Reason: Tritanium Patella Inserter Instrument fracture during implantation. . - Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right S…
FDA Device · Class II · 2014-04-09 · Stryker Howmedica Osteonics
Reason: Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40… - Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive…
FDA Device · Class II · 2014-02-19 · Stryker Howmedica Osteonics
Reason: Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. - Stryker CMF Customized Implant Kit X-Large
FDA Device · Class II · 2014-02-19 · Stryker Howmedica Osteonics
Reason: Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. - Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: St…
FDA Device · Class II · 2014-02-05 · Stryker Howmedica Osteonics
Reason: Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile. - Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery
FDA Device · Class II · 2014-01-01 · Stryker Howmedica Osteonics
Reason: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. - Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery
FDA Device · Class II · 2014-01-01 · Stryker Howmedica Osteonics
Reason: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. - Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp
FDA Device · Class II · 2013-12-18 · Stryker Howmedica Osteonics
Reason: Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. - 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Dr…
FDA Device · Class II · 2013-12-18 · Stryker Howmedica Osteonics
Reason: Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. - Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Pro…
FDA Device · Class II · 2013-09-04 · Stryker Howmedica Osteonics
Reason: Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. - Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat
FDA Device · Class II · 2013-09-04 · Stryker Howmedica Osteonics
Reason: Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. - GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A si…
FDA Device · Class II · 2013-08-07 · Stryker Howmedica Osteonics
Reason: Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. - Stryker Orthopaedics Triathlon Femoral Distal Augment- Left
FDA Device · Class II · 2013-05-29 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment.… - Stryker Howmedica Osteonics Corp
FDA Device · Class II · 2013-05-08 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the su… - ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation…
FDA Device · Class I · 2013-04-24 · Stryker Howmedica Osteonics
Reason: With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting G… - Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments
FDA Device · Class II · 2013-04-17 · Stryker Howmedica Osteonics
Reason: Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly. - Howmedica Osteonics Corp
FDA Device · Class II · 2013-03-27 · Stryker Howmedica Osteonics
Reason: The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed. - Command Instrument Broach Handle
FDA Device · Class II · 2013-03-20 · Stryker Howmedica Osteonics
Reason: Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. - Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003
FDA Device · Class II · 2013-01-23 · Stryker Howmedica Osteonics
Reason: Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. - Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteon…
FDA Device · Class II · 2013-01-16 · Stryker Howmedica Osteonics
Reason: Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. - Stryker Howmedica Osteonics
FDA Device · Class II · 2013-01-02 · Stryker Howmedica Osteonics
Reason: During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. - Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporat…
FDA Device · Class II · 2012-12-12 · Stryker Howmedica Osteonics
Reason: Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not inc… - Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporat…
FDA Device · Class II · 2012-12-12 · Stryker Howmedica Osteonics
Reason: Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not inc… - Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon ele…
FDA Device · Class II · 2012-11-28 · Stryker Howmedica Osteonics
Reason: Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a… - Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon ele…
FDA Device · Class II · 2012-11-28 · Stryker Howmedica Osteonics
Reason: Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a… - Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a compone…
FDA Device · Class II · 2012-11-21 · Stryker Howmedica Osteonics
Reason: Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. - Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corpor…
FDA Device · Class II · 2012-11-14 · Stryker Howmedica Osteonics
Reason: Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. - Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland
FDA Device · Class II · 2012-10-10 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared i… - Tibial Punch Tower Assembly
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was… - ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics
Reason: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associa… - Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryke…
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics
Reason: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associa… - Stryker T2 Arthrodesis Nailing System
FDA Device · Class II · 2012-07-25 · Stryker Howmedica Osteonics
Reason: Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. - Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107
FDA Device · Class II · 2012-07-18 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. - Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France…
FDA Device · Class II · 2012-06-27 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.