Device product
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Z-2086-2014
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 68341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2086-2014
Official wording
Reason: The femoral stem is lacking specified plasma coating.
Code information: Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
Distribution pattern: Worldwide Distribution including Spain, Greece and Japan
Derived failure modes
-
Unknown
The femoral stem is lacking specified plasma coating.