Home / Recalls / Cayenne Medical Inc. / Z-2422-2018

Z-2422-2018 Class II Terminated

Recalled by Cayenne Medical Inc. — Scottsdale, AZ

Recall Details

Product Type: Devices
Report Date: July 18, 2018
Initiation Date: July 11, 2013
Termination Date: September 14, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 976 units

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.

Reason for Recall

Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.

Distribution Pattern

US nationwide distribution.

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).