FDA-Device2018-03-21Class II
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)
Zimmer Biomet, Inc.
Hazard
Two lots of hip implants are mislabeled.
Sold states
Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Affected count
24
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2018Don't want to check this manually?
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