Trabecular Metal¿ Primary Hip Prosthesis recalled over labeling errors
- Recall date
- January 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zimmer Biomet, Inc. recalls Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63…
- Recall number
- Z-0939-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Why it was recalled
Two lots of hip implants are mislabeled.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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)
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