Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 86 units of the XP-XP Tibial Tray because the locking bar may not fully engage. The recall covers units distributed across the US and several international regions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Zimmer Biomet, Inc. is recalling 86 units of the XP-XP Tibial Tray - Interlok 91mm (Item # 195761). The recall was initiated because the locking bar on the device may not fully engage. The affected units are identified by specific lot numbers, including 183700, 790980, and 202030, among others.
The recalled devices were distributed to facilities in numerous US states, including New York, Indiana, Ohio, and California, as well as to international locations such as Korea, China, Canada, and Australia. The agency has classified this recall as Class II.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to manage the affected devices. Consumers should not use the recalled tibial trays until further notice.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 91mm Item # 195761
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 86
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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