Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of 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 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 is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves a sterile medical device with potential cleaning deficiencies, which poses a risk of infection or other harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. 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, including to numerous states in the United States.
The recall covers specific lot numbers and UDI numbers listed in the official FDA record. The products are sterile medical devices intended for use in hip surgery. The identified issue relates to the manufacturing process, specifically the cleaning steps, which may not have been performed or monitored adequately.
Consumers and healthcare providers should check their inventory 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. or the distributor according to the instructions provided in the official recall notice.
The recalled product
- Product
- BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
- 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*** 623210
- 636020
- 822620
- 865060
- 823110
- 922950
- 234200
- 556590
- 801160
- 919620
- 115650
- 401230
- 382910
- 508910
- 189900
- 534730
- 009800
- 280090
- 844520
- 297620
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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