Biomet Compress Face Reamer Recalled for Missing Helix Angle
Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet, Inc. is recalling four units of the Compress Face Reamer (Catalog numbers 32-481000 and 32-481001). The affected units are identified by specific lot numbers: 615860, 765230, 121450, 392410, 765250, and 974290.
The recall was initiated after an investigation determined that the supplied units were missing the 4x21 degree helix angle. This product is used for the correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
The affected units were distributed internationally in the Netherlands, Europe, the Middle East, and Asia. Healthcare providers should stop using the affected units and contact Biomet, Inc. for further instructions.
The recalled product
- Product
- Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 4
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 (5)
- Catalog numbers: 32-481000 Lot Numbers: 615860
- 765230 Catalog Number: 32-481001 Lot Number Identification: 121450
- 392410
- 765250
- 974290
Distribution
Distribution scope not specified by the agency.
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