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U.S. Department of Health and Human Services

Class 2 Device Recall AperFix Femoral Implant

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  Class 2 Device Recall AperFix Femoral Implant see related information
Date Initiated by Firm July 11, 2013
Create Date July 10, 2018
Recall Status1 Completed
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 2
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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = CAYENNE MEDICAL, INC.
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