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Biomet, Inc. recalls Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Recalled June 12, 2013 · FDA recall Z-1465-2013 · Biomet
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. · FDA Class II
Units
8 units
Sold at
Distributed in New York.
Description
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.
Product
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →