Reported Sep 26, 2012 · Terminated
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith…
Smith & Nephew Inc.
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: Smith & Nephew Inc · 1450 E. Brooks Rd · Memphis, TN · 38116
Is this the product you have?
- 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
- Lot codes and dates
- Lot Numbers
12FTM0017A12FTM0017B12FTM0017C12FTM0019A. 12FTM0019B12FTM0019C12FTM0019D12FTM0020A12FTM0020B12FTM0020C12FTM0021A12FTM0021Band 12FTM0021C
- Lot Numbers
- Amount recalled
- 70 units
Where it was sold
Why it was recalled
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
This product could cause temporary or reversible health problems — stop using it.
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