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Recall Observatory FDA recall evidence

Device product

PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

Z-1712-2014

April 30, 2014

Class II

Product summary

Firm
Microport Orthopedics INC.
Event
Event 68326
Status
Terminated
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-1712-2014

Official wording

Reason: Difficulty removing the cup adaptor from the impaction handle during surgery

Code information: Lot Number(s): 1153896, 1279714, 1288604, and 1314793

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Difficulty removing the cup adaptor from the impaction handle during surgery