Class II — Cayenne Medical Inc.
| Recalling firm | CAYENNE MEDICAL, INC. |
|---|---|
| Registered facility | CAYENNE MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. |
| Product | 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. |
| Quantity | 976 units |
| Distribution | US nationwide distribution. |
| Initiated | 2013-07-11 |
| Classified | 2018-07-10 |
| Terminated | 2018-09-14 |
| Recall number | Z-2422-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cayenne Medical Inc. (Z-2422-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80282/
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