Cayenne Medical Inc. recalls AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in liga…
- Recall date
- July 11, 2013
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2422-2018
- FDA classification
- Class II
- Brand / firm
- Cayenne Medical Inc.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
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