Z-0939-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

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