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.
Reported: April 8, 2015 Initiated: February 24, 2015 #Z-1352-2015
Product 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.
Reason for Recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 131
- Distribution
- US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synthes, Inc.. Units affected: 131.
Why was this product recalled? ▼
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2015. Severity: Moderate. Recall number: Z-1352-2015.
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