Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect
Zimmer Biomet is recalling 78 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 involves a structural defect in a medical implant where the locking bar may not fully engage. This presents a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 78 units of the XP-CR Tibial Tray - Interlok 87 mm (Item # 195278). The recall is due to a defect where the locking bar may not fully engage.
The affected units were distributed across numerous U.S. states and internationally to countries including Korea, China, Canada, Australia, Japan, and various regions in Europe. Specific lot numbers for the recalled units include 966230, 262470, 587200, 274370, 274360, 274380, 274420, 715690, 274420R, 715690R, 393650, 279080, 394490, 821380, 903430, 943440, 422480, and 512580.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 87 mm Item # 195278
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 78
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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