Device product
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
Z-0939-2018
Product summary
- Event
- Event 79397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0939-2018
Official wording
Reason: Two lots of hip implants are mislabeled.
Code information: Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681
Distribution pattern: Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Derived failure modes
-
Labeling or packaging
mislabeled