Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 906 units of the XP-XP Tibial Tray 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 (locking bar not fully engaging) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 906 units of the XP-XP Tibial Tray - Interlok 73 mm (Item # 195756). The recall was initiated because the locking bar on the device may not fully engage.
The affected products were distributed across numerous U.S. states and internationally to countries including Korea, China, Canada, Australia, Japan, Sweden, Italy, and the EMEA region. The recall covers a wide range of lot numbers, including 562200, 664340, and 613420, among others.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices. The source text does not specify reported injuries or illnesses associated with this defect.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 73 mm Item # 195756
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 906
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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