Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling 319 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 is classified as FDA Class II. The hazard 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 specific 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 319 units of the XP-CR Tibial Tray - Interlok 79 mm (Item # 195276). The recall is due to a defect where the locking bar may not fully engage.
The affected devices were distributed across numerous U.S. states and internationally to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. The recall covers specific lot numbers, including 663820, 503480, and 262450, among others.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 79 mm Item # 195276
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 319
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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