FDA-Device2015-04-08Class II
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.
Synthes, Inc.
Hazard
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Sold states
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Affected count
131
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2015Don't want to check this manually?
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