Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect
Zimmer Biomet is recalling 454 units of XP-CR Tibial Trays 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 structural defect in a medical implant (locking bar not fully engaging) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 454 units of the XP-CR Tibial Tray - Interlok 71mm (Item # 195273). The recall was initiated because the locking bar on the device may not fully engage.
The affected units were distributed across numerous US states and internationally to countries including Korea, China, Canada, Australia, Japan, and various European regions. Specific lot numbers are listed in the official recall documentation.
Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to proceed with the recall. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 71mm Item # 195273
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 454
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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