Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is described as a process monitoring issue without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207. 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 numerous states in the United States. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and UDI numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Biomet, Inc. according to the instructions provided in the recall communication.
The recalled product
- Product
- BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
- 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*** 964120
- 668270
- 595770
- 400860
- 854840
- 867720
- 867770
- 386480
- 539790
- 700450
- 930290
- 215340
- 457040
- 615020
- 588170
- 588180
- 963900
- 963890
- 737920
- 805810
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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