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