Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect
Zimmer Biomet is recalling 375 units of the XP-CR Tibial Tray - Interlok 65mm because the locking bar may not fully engage.
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 mechanical defect that could lead to device failure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 375 units of the XP-CR Tibial Tray - Interlok 65mm (Item # 195270). The recall is due to a defect where the locking bar may not fully engage.
The affected product was distributed to multiple U.S. states, including New York, Indiana, Ohio, and Michigan, as well as international locations such as Korea, China, Canada, and Australia. Specific lot numbers are listed in the agency's recall record.
Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices. The U.S. Food and Drug Administration has classified this recall as Class II.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 65mm Item # 195270
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 375
Distribution
Part of a larger recall action
This product is one of 35 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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