Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterility/cleaning defect, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. The recall involves 230,001 units that were distributed worldwide and to specific states in the United States.
The recall was initiated due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. This issue could affect the sterility or cleanliness of the medical device.
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected devices and contact Biomet for instructions on how to return or dispose of them. Patients who have already had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
- Manufacturer
- Biomet, Inc.
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*** 004800
- 104440
- 734050
- 082110
- 912150
- 961960
- 092470
- 630170
- 602290
- 357210
- 508930
- 474100
- 913740
- 364330
- 396650
- 295210
- 854280
- 952930
- 816110
- 362340
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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