Device product
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Z-1249-2015
Product summary
- Event
- Event 70477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-1249-2015
Official wording
Reason: Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Code information: Lot Numbers: 1560140, 15601401568897, 15601401570896
Distribution pattern: Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
Derived failure modes
-
Unknown
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.