Biomet Recalls Active Articulation E1 Hip Bearing Implants Due to Labeling Errors
Biomet is recalling 8 units of Active Articulation E1 hip bearing implants because outer and inner labels display incorrect or conflicting outer diameter sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error where the physical implant is correctly etched, fitting the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Biomet, Inc. is recalling 8 units of Active Articulation E1 hip bearing implants. These medical devices are intended for use with either primary or revision hip arthroplasty. The recall was initiated after an investigation identified labeling discrepancies on the product packaging.
The investigation found that the outer label indicates two conflicting outer diameter (O.D.) sizes, while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size. The affected units are identified by part numbers EP-200162, EP-200164, and EP-200166, and specific lot numbers including 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
The affected units were distributed in New York. Healthcare providers and patients should verify the part and lot numbers of any implanted or stocked devices against the recall list. If a device matches the recalled specifications, it should be removed from use and reported to Biomet, Inc.
The recalled product
- Product
- Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Part numbers: EP-200162
- EP-200162
- EP-200164
- and EP-200166 with Lot numbers: 027050
- 101470
- 115950
- 101480
- 247990
- 948810
- 967270
- 027070
- 287820
- 729870
- and 860880.
Distribution
Distributed in 1 state:
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