Reported Apr 8, 2015 · Terminated
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part…
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 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.
- Lot codes and dates
- Part Numbers
03.037.01303.037.014
- Lot Numbers
890384891240179038519124019891856691240229124012912402391240149124026912401691240278918563
- Part Numbers
- Amount recalled
- 131
Where it was sold
Why it was recalled
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
This product could cause temporary or reversible health problems — stop using it.
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