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
    • 03.037.013
    • 03.037.014
  • Lot Numbers
    • 8903848
    • 9124017
    • 903851
    • 9124019
    • 8918566
    • 9124022
    • 9124012
    • 9124023
    • 9124014
    • 9124026
    • 9124016
    • 9124027
    • 8918563
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 21, 2015 · Data as of Sep 19, 6:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.