Device product
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.
Z-2427-2012
Product summary
- Event
- Event 63089
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-2427-2012
Official wording
Reason: Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Code information: Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C
Distribution pattern: 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.
Derived failure modes
-
Potency or specification failure
out of specification