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Recall Observatory FDA recall evidence

Device product

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

Z-0821-2017

December 07, 2016

Class II

Product summary

Firm
Stanmore Implants Worldwide Ltd.
Event
Event 75892
Status
Terminated
Classification
Class II
Quantity
51 units
Official record key
device-enforcement:Z-0821-2017

Official wording

Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Code information: A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229

Distribution pattern: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.