Recall archive
48 recalls · page 2 of 2
Reported Feb 19, 2014
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be…
FDA (openFDA device enforcement)
Reported Jan 1, 2014
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2013
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2013
Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2013
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
FDA (openFDA device enforcement)
Reported May 29, 2013
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted…
FDA (openFDA device enforcement)
Reported May 8, 2013
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker…
FDA (openFDA device enforcement)
Reported Apr 24, 2013
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Stryker Howmedica Osteonics Corp.
Matched: Brand · Reason for recall — With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with…
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
FDA (openFDA device enforcement)
Reported Mar 27, 2013
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
FDA (openFDA device enforcement)
Reported Jan 23, 2013
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
FDA (openFDA device enforcement)
Reported Jan 16, 2013
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product details · Reason for recall — Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
FDA (openFDA device enforcement)
Reported Jan 2, 2013
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
FDA (openFDA device enforcement)
Reported Dec 12, 2012
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2012
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Reason for recall — Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
FDA (openFDA device enforcement)
Reported Nov 14, 2012
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight…
FDA (openFDA device enforcement)
Reported Oct 10, 2012
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Aug 1, 2012
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2012
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee…
FDA (openFDA device enforcement)
Reported Jul 18, 2012
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
FDA (openFDA device enforcement)
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