Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
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 describes a potential process issue without reporting specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling the BIOMET StageOne Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. The recall was initiated because of a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Approximately 230,001 units were distributed worldwide, including to hospitals and medical facilities in the United States. The affected products are sterile silicone molds used in shoulder surgery to shape bone cement.
Biomet is working with the FDA to address the issue. Healthcare providers should stop using the affected lots and contact Biomet for further instructions. Patients who have had surgery using these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
- 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*** 860710
- 215430
- 555230
- 583850
- 089660
- 283370
- 132850
- 372710
- 372760
- 181880
- 357230
- 409110
- 409190
- 765360
- 196690
- 196700
- 196710
- 338960
- 511930
- 549800
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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