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MicroPort Orthopedics, Inc. recalls PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedi
Recalled October 7, 2015 · FDA recall Z-2743-2015 · MicroPort Orthopedics
Hazard
Unexpected rate of postoperative fractures resulting in the need for revision surgery. · FDA Class I
Units
10,489 units
Sold at
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.
Description
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Product
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
Manufacturer(s)
MicroPort Orthopedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →