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Recall Observatory FDA recall evidence

Device product

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Z-2091-2015

June 10, 2015

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 71492
Status
Terminated
Classification
Class II
Quantity
32
Official record key
device-enforcement:Z-2091-2015

Official wording

Reason: The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

Code information: Part Number Lot Numbers 03.037.024 T102759

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).