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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cayenne Medical Inc.
- Reason for Recall:
- Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2422-2018
Related Recalls
A review of complaints identified a trend for drills breaking.
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.