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Recall Observatory FDA recall evidence

Device product

PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

Z-2743-2015

August 04, 2015

Class I

Product summary

Firm
MicroPort Orthopedics, Inc.
Event
Event 71925
Status
Terminated
Classification
Class I
Quantity
10,489 units
Official record key
device-enforcement:Z-2743-2015

Official wording

Reason: Unexpected rate of postoperative fractures resulting in the need for revision surgery.

Code information: All lot codes

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unexpected rate of postoperative fractures resulting in the need for revision surgery.