Biomet Recalls Knee Spacer Molds Due to Insufficient Cleaning Process
Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning or inadequate process monitoring.
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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
The affected products were distributed worldwide, including to all 50 U.S. states and the District of Columbia. The recall covers numerous specific lot numbers and UDI numbers, which are listed in the official FDA record.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients should check their inventory and patient records for the affected lot numbers and contact Biomet, Inc. for further instructions on how to proceed.
The recalled product
- Product
- BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
- Manufacturer
- Biomet, Inc.
- Affected units
- 230,001
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 (20)
- ***Lot Numbers*** 410380
- 036380
- 095880
- 095890
- 095900
- 096130
- 096260
- 096310
- 096340
- 096280
- 242320
- 242340
- 242360
- 318790
- 527250
- 527260
- 527950
- 527240
- 527970
- 527990
Distribution
Part of a larger recall action
This product is one of 33 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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