Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563
- 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:
- Synthes, Inc.
- Reason for Recall:
- The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Product Codes/Lot Numbers:
Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1352-2015
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