Zimmer Biomet Recalls XP-CR Tibial Tray Due to Locking Bar Defect
Zimmer Biomet is recalling 369 units of the XP-CR Tibial Tray - Interlok 75mm 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 where the locking bar may not fully engage, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 369 units of the XP-CR Tibial Tray - Interlok 75mm (Item # 195275). The recall was initiated because the locking bar on the device may not fully engage.
The affected units were distributed across numerous U.S. states, including New York, Indiana, Ohio, and Michigan, as well as internationally to countries such as Korea, China, Canada, and Australia. The recall covers specific lot numbers, including 663790, 262440, and 513090.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to return the affected devices or obtain replacements. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 75mm Item # 195275
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 369
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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