FDA-Device2015-10-07Class I
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
MicroPort Orthopedics, Inc.
Hazard
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Sold states
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.
Affected count
10,489 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
Products
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2743-2015Don't want to check this manually?
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