MicroPort Orthopedics, Inc. recalls PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hi…

Recall date

August 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2743-2015

FDA classification

Class I

Brand / firm

MicroPort Orthopedics, Inc.

Sold / distributed

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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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