Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues
Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific total elbow replacement devices, including LT and RT Disc Ulna, LT and RT Disc HMRL, Disc XS Ulna Por, Disc Seg Ulna Por, and custom devices. The recall affects approximately 217,240 units distributed nationwide in the United States and in various international countries, including Argentina, Australia, Brazil, Canada, and others.
The recall was initiated because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the removal or replacement of these devices. Consumers should not use the affected products and should follow the guidance provided by the manufacturer and regulatory authorities.
The recalled product
- Product
- LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 217,240
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Zimmer 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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