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Browse Device Recalls

87 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 87 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 87 FDA device recalls.

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DateProductReasonClassFirm
Aug 15, 2014 Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Jul 24, 2014 Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-... Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a differ... Class II Stryker Howmedica Osteonics Corp.
May 1, 2014 Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE P... Tritanium Patella Inserter Instrument fracture during implantation. . Class II Stryker Howmedica Osteonics Corp.
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics Corp.
Dec 6, 2013 Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) ... Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customi... Class II Stryker Howmedica Osteonics Corp.
Nov 20, 2013 Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single u... Stryker received reports from the field of the impaction plate dissociating/fracturing from the m... Class II Stryker Howmedica Osteonics Corp.
Nov 7, 2013 Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher S... Stryker became aware during laboratory testing that there is a potential that the seal integrity ... Class II Stryker Howmedica Osteonics Corp.
Oct 25, 2013 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Ang... Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was iden... Class II Stryker Howmedica Osteonics Corp.
Oct 10, 2013 VariAx Compression Plating System Stryker received two reports indicating that during screw insertion under a high lateral angle a ... Class II Stryker Howmedica Osteonics Corp.
Oct 1, 2013 Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry... Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM sur... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surg... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Jul 8, 2013 Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) ... Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot... Class II Stryker Howmedica Osteonics Corp.
Jul 2, 2013 Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedul... Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. Class II Stryker Howmedica Osteonics Corp.
May 21, 2013 GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedic... Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. Class II Stryker Howmedica Osteonics Corp.
Mar 28, 2013 Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Loc... Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Dril... Class II Stryker Howmedica Osteonics Corp.
Mar 25, 2013 Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... Class II Stryker Howmedica Osteonics Corp.
Feb 23, 2013 Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. How... Stryker received reports from the field indicating that the handle detached from the cam of the B... Class II Stryker Howmedica Osteonics Corp.
Jan 24, 2013 Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and ... The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" ... Class II Stryker Howmedica Osteonics Corp.
Dec 20, 2012 Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog N... Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. Class II Stryker Howmedica Osteonics Corp.
Nov 8, 2012 ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides ar... With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become awa... Class I Stryker Howmedica Osteonics Corp.
Oct 25, 2012 Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Two complaints have been filed where Hoffman LRF Wires have broken during load bearing applicatio... Class II Stryker Howmedica Osteonics Corp.
Oct 23, 2012 Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF... Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting i... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 6, 2012 Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile;... During the manufacturing of the affected lot a manufacturing error has led to embrittlement of th... Class II Stryker Howmedica Osteonics Corp.
Jul 27, 2012 Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS R... Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... Class II Stryker Howmedica Osteonics Corp.
Jul 27, 2012 Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS ... Offset Bushings associated with the lots identified were mismarked: the rotational reference numb... Class II Stryker Howmedica Osteonics Corp.
Jul 16, 2012 Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extens... Stryker has become aware that insufficient taper torsional strength may result when a PAR extensi... Class II Stryker Howmedica Osteonics Corp.
Jul 3, 2012 Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seiza... Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load ... Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2012 Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate C... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2012 ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 ... Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and R... Class II Stryker Howmedica Osteonics Corp.
Apr 2, 2012 Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Ca... Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal thr... Class II Stryker Howmedica Osteonics Corp.
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.
Dec 29, 2011 Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics ... Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle A... Class II Stryker Howmedica Osteonics Corp.
Dec 29, 2011 Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-0... Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their ... Class II Stryker Howmedica Osteonics Corp.
Dec 22, 2011 Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Ost... Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted ... Class II Stryker Howmedica Osteonics Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.