Reported Sep 21, 2016 · Terminated
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an…
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 Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
- Lot codes and dates
- Catalog number 18251032S and Lot Code K288335
- Amount recalled
- 1 unit in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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