Class 2 Device Recall AperFix Femoral Implant

• Date Initiated by Firm: July 11, 2013
• Create Date: July 10, 2018
• Recall Status: Terminated on September 14, 2018
• Recall Number: Z-2422-2018
• Recall Event ID: 80282
• 510(K)Number: K083612
• Product Classification: Screw, fixation, bone - Product Code HWC
• 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.
• 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).
• Recalling Firm/ Manufacturer: Cayenne Medical Inc.; 16597 N 92nd St Ste 101; Scottsdale AZ 85260-1847
• For Additional Information Contact: Kevin Escapule; 574-372-4487
• Manufacturer Reason for Recall: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
• FDA Determined Cause: Device Design
• Action: Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand.
• Quantity in Commerce: 976 units
• Distribution: US nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC and Original Applicant = CAYENNE MEDICAL, INC.