FDA-Device2013-06-12Class II
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Biomet, Inc.
Hazard
Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
Sold states
Distributed in New York.
Affected count
8 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2013Don't want to check this manually?
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