Stanmore Implants Worldwide Ltd. recalls Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
- Recall date
- April 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1623-2016
- FDA classification
- Class II
- Brand / firm
- Stanmore Implants Worldwide Ltd.
- Sold / distributed
- US distribution to OH.
Why it was recalled
Incorrect component used to manufacture distal femoral replacement.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
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