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Recall Observatory FDA recall evidence

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

August 22, 2012

Class II

Product summary

Firm
Smith & Nephew Inc
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

    reason.potency_specification_failure · v1.0.0

    out of specification