FDA recall Z-0939-2018

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)

Reason for recall

Two lots of hip implants are mislabeled.

Distribution

Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.

Key facts

Status

Terminated

Initiation date

2018-01-03

Report date

2018-03-21

Termination date

2019-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2018