Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error
Biomet, Inc. is recalling specific lots of Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.
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 involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet, Inc. is recalling six units of Part 475630, Intramedullary Bone Saw, Cam Assembly, Size 14 mm. The recall involves specific lots (239470, 457450) that were distributed worldwide, including in the United States (New York, Texas, Michigan, and Minnesota) and in Australia and The Netherlands.
The recall was initiated due to incorrect labeling. The affected items were identified as CAM Assembly but were labeled as Saw Blade Assembly. The Intramedullary Bone Saw is a clinical instrument used to correct leg length or rotational discrepancies in the femur.
Healthcare facilities and distributors should stop using the affected lots and contact Biomet, Inc. for instructions on returning the products. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 6
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 (2)
- Lot 239470
- 457450
Distribution
Part of a larger recall action
This product is one of 3 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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