Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels
Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.
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 contamination hazard (endotoxin) that could cause harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling one unit of a custom-made knee prosthesis, specifically the TMJPM-1510 Microfixation Left PM-TMJ Model. The recall is being conducted because of the potential presence of elevated endotoxin levels that exceed the established specification limit for the device.
The affected product is identified by the UDI (01)00841036226534(17)220111(10)735550 and Lot Number 735550. The device was distributed worldwide, including in the United States, Canada, India, Japan, Mexico, the Netherlands, Singapore, and other international locations.
Consumers and healthcare providers who have this specific device should contact Biomet, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 1
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 (1)
- Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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