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Recall Observatory FDA recall evidence

Device product

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Z-0474-2014

July 30, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66409
Status
Terminated
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-0474-2014

Official wording

Reason: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Code information: Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Distribution pattern: Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling