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Recall Observatory FDA recall evidence

Device product

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

Z-0604-2018

July 21, 2017

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 78958
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0604-2018

Official wording

Reason: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

Code information: Lot H302839, Expiration Date 31Jan2026

Distribution pattern: TX, GA, PA, UT and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.