FDA Medical Device Recalls (openFDA)
Cayenne Medical Inc.: 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.
- Recall number
- Z-2422-2018
- Recalling firm
- Cayenne Medical Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-07-11
- Posted
- not on file
- Terminated
- 2018-09-14
- Reason
- Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
- Root cause
- Device Design
- Action
- Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand.
- Quantity
- 976 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Item Number (Lot Number): CM-2409 (40731-2, 40743-5, 41049-1, 41237-2, 41536-2, 41737-2, 42219-2), CM-2410 (40731-3, 40743-6, 41049-2, 41237-3, 41536-3, 41737-3, 42219-3).
- 510(k) numbers
- ["K083612"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3006108336
- Firm city
- Scottsdale
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28