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Terminated

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.

FDA Recall Z-2422-2018 · Posted None

Recalling FirmCayenne Medical Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-07-11
Date Terminated2018-09-14
Product Quantity976 units

Reason for Recall

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

Firm Action

Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand.

Root Cause

Device Design

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083612APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MMCayenne Medical, Inc. · 2009-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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