Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of 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 describes a potential process monitoring issue without reporting any specific injuries, illnesses, or deaths, which aligns with the criteria for a Moderate severity score.
Plain-English summary
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182. The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
The affected products were distributed worldwide and to numerous U.S. states, including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia. Specific lot numbers and UDI numbers are listed in the official recall record.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and UDI numbers associated with this recall. If the product is found, it should be removed from use and returned to Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
- 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*** 572290
- 961940
- 769090
- 961950
- 982370
- 321690
- 623220
- 636030
- 853960
- 050730
- 050740
- 082030
- 020960
- 201900
- 234210
- 392780
- 556600
- 846260
- 171620
- 401240
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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