Z-0939-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- January 3, 2018
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
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)
Reason for Recall
Two lots of hip implants are mislabeled.
Distribution Pattern
Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Code Information
Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681