Reported Jan 21, 2015 · Terminated
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee…
Stelkast Co.
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: Stelkast Co · 200 Hidden Valley Rd · Mcmurray, PA · 15317-2659
Is this the product you have?
- EXp Tibial Insert
- Intended Use of Device(s)The Proven Gen-Flex
- Total Knee System is intended fora. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present
- Lot codes and dates
- part numbers SC3425 and SC3453
- with lot numbers
149 of 149 codes
28592-10311228593-10241228602-11011228603-11011228613-11011228617-11011228618-11011228622-11281228623-11281228624-11281231031-12101331033-12101331040-12101331249-02251431261-02041428592-10311228593-10241228598-11141228599-11141228602-11011228603-11011228607-11191228613-11011228617-11011228618-11011228622-11281228623-11281228624-11281231029-12091331040-12101331043-12091331243-02241431244-02241431249-02251431252-02131431255-02041431261-02041432083-08071431028-12091331031-12101331032-12101331033-12101331042-12101331044-12091331243-02241431244-02241431245-02241431252-02131431255-02041431261-02041431263-02131431264-03111431265-03111431266-03111428592-10311228593-10241228598-11141228599-11141228602-11011228603-110112
- Amount recalled
- 553
Where it was sold
Why it was recalled
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
This product could cause temporary or reversible health problems — stop using it.
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