FDAFDA · Food and drugs·Recall number Z-2427-2012
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.
Published September 26, 2012 · Recall initiated: August 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
- Lot
- Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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