Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 1,210 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 is classified as FDA Class II, and the hazard involves a structural failure of a medical implant (locking bar not engaging) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,210 units of the XP-XP Tibial Tray - Interlok 67 mm (Item # 195753). The recall is being conducted because the locking bar on the device may not fully engage.
The affected products were distributed to facilities in numerous U.S. states and internationally, including locations in Korea, China, Canada, Australia, Japan, and Europe. The recall covers a wide range of specific lot numbers, which are listed in the official FDA recall record Z-2524-2019.
Healthcare providers and patients who have received this specific implant should contact their orthopedic surgeon or Zimmer Biomet to determine if the device is affected and to discuss appropriate clinical management.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 67 mm Item # 195753
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,210
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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