Recall Z-2422-2018— Cayenne Medical Inc.

Name: FDA recall Z-2422-2018
Creator: U.S. Food and Drug Administration
Published: 2013-07-11

Class II · Terminated

Class II FDA medical device recall by Cayenne Medical Inc., initiated 2013-07-11, terminated 2018-09-14. It names one FDA 510(k) clearance: K083612. 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.. Reason: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket..

Recalling firm: Cayenne Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-11
Terminated: 2018-09-14
Firm location: Scottsdale, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K083612 — APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MMCayenne Medical, Inc.·cleared 2009-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.