Reported Apr 17, 2013 · Terminated
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.…
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?
- Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
- Lot codes and dates
Part Numbers SC3458-52lot number 28820-112612SC3474-52lot number 28822-101812SC3459-52lot number 28823-101812and SC3460-52lot number 28821-000
- Amount recalled
- 254
Where it was sold
Why it was recalled
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
This product could cause temporary or reversible health problems — stop using it.
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