Biomet Recalls Knee Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
What this means for you
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. The hazard involves a potential process failure (cleaning) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling the BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170. The recall involves 230,001 units distributed worldwide, including to all 50 U.S. states and the District of Columbia.
The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
Healthcare providers and facilities should stop using the affected devices and contact Biomet, Inc. for further instructions. Consumers should not use these sterile medical devices if they have them in their possession.
The recalled product
- Product
- BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
- 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*** 606370
- 049930
- 959120
- 036410
- 036420
- 095910
- 096360
- 959140
- 318800
- 527300
- 528020
- 527270
- 527280
- 527290
- 528000
- 528030
- 688320
- 688330
- 729300
- 857840
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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