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Recall Observatory FDA recall evidence

Device 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.

Z-1352-2015

February 24, 2015

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 70579
Status
Terminated
Classification
Class II
Quantity
131
Official record key
device-enforcement:Z-1352-2015

Official wording

Reason: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Code information: Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563

Distribution pattern: US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Field note

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