Biomet Knee Spacer Mold Recalled for Potential Cleaning Deficiencies
Biomet is recalling StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
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, 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 the BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175. The recall involves 230,001 units that were distributed worldwide and to specific states in the United States.
The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. This issue may affect the sterility or cleanliness of the medical device.
Healthcare providers and facilities that have received these products should stop using them and contact Biomet for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
- Manufacturer
- Biomet, Inc.
- Hazard
- 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*** 593990
- 240410
- 417130
- 893160
- 959150
- 527310
- 527330
- 527320
- 600520
- 688340
- 729310
- 976980
- 976990
- 145250
- 239320
- 310120
- 496420
- 496430
- 680300
- 757940
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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