Cayenne Medical Inc.: Medical Device Recall in 2018 - (Recall #: Z-2422-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: July 11, 2013
Date Posted: July 18, 2018
Recall Number: Z-2422-2018
Event ID: 80282
Reason for Recall:
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Status: Terminated
Product Quantity: 976 units
Code Information:
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).
Distribution Pattern:
US nationwide distribution.
Voluntary or Mandated:
Voluntary: Firm initiated