Zimmer Biomet Recalls HHR Tess Cleats Due to Bacterial Endotoxin
Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices 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 medical device with a contamination hazard (bacterial endotoxin) where no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Comprehensive HHR Tess Cleat, Item Nos. 110260, 110261, 110262, and 110263. The recall involves 219,988 units that were distributed nationwide in the United States and in 24 other countries, including Argentina, Australia, Brazil, Canada, and Japan.
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 specify the exact nature of the cleaning failure or the specific endotoxin levels detected.
Healthcare providers and patients who have received these devices should contact Zimmer Biomet for further instructions on how to proceed. The source text does not provide specific contact information or a deadline for the recall.
The recalled product
- Product
- Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
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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