Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 973 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect involves a mechanical failure (locking bar not fully engaging) in a medical device, 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 973 units of the XP-XP Tibial Tray - Interlok 75 mm (Item # 195757). The recall was initiated because the locking bar on the device may not fully engage.
The affected product was distributed across numerous U.S. states and internationally to countries including Korea, China, Canada, Australia, Japan, Sweden, Italy, and other EMEA regions. The recall covers a wide range of lot numbers, including 664400, 664380, 677580, and many others listed in the agency's records.
This is an FDA Class II recall. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 75 mm Item # 195757
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 973
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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