Reported Oct 10, 2012 · Terminated
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
- Lot codes and dates
- Catalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm std cone trial 6278-1-031 Mod Rev 31 mm std cone trial 6278-1-119 Mod Rev 19 mm + 10 mm cone trial 6278-1-121 Mod Rev 21mm + 10 mm cone trial 6278-1-123 Mod Rev 23mm + 10 mm cone trial 6278-1 -125 Mod Rev 25 mm + 10 mm cone trial 6278-1-127 Mod Rev 27mm + 10 mm cone trial 6278-1-129 Mod Rev 29mm + 10mm cone trial 6278-1-131 Mod Rev 31mm + 10 mm cone trial 6278 -1-219 Mod Rev 19mm + 20 mm cone trial 6278-1-221 Mod Rev 21mm +20 mm cone trial 6278-1-223 Mod Rev 23mm + 20 mm cone trial 6278-1-225 Mod Rev 25mm + 20 mm cone trial 6278-1-227 Mod Rev 27mm + 20 mm cone trial 6278-1-229 Mod Rev 29mm + 20 mm cone trial 6278-1-231 Mod Rev 31mm + 20 mm cone trial 6278-1-319 Mod Rev 19mm + 30 mm cone trial 6278-1-321 Mod Rev 21mm +30 mm cone trial 6278-1-323 Mod Rev 23mm + 30 mm cone trial 6278-1-325 Mod Rev 25mm + 30 mm cone trial 6278-1-327 Mod Rev 27mm + 30 mm cone trial 6278-1-329 Mod rev 29mm +30 mm cone trial 6278-1-331 Mod Rev 31mm + 30 mm cone trial 1 single unit to each non-sterile package Numerous lots numbers please see attachment.
- Amount recalled
- 10, 983 units
Where it was sold
- Nationwide
Why it was recalled
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 in cross section.
This product could cause temporary or reversible health problems — stop using it.
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