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Synthes, Inc. recalls Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part
Recalled April 8, 2015 · FDA recall Z-1352-2015 · Synthes
Hazard
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. · FDA Class II
Units
131
Sold at
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Description
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Product
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.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →