Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling 2 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 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the structural nature of the defect in a load-bearing medical device.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2 units of the XP-CR Tibial Tray - Porous Plasma 91 mm (Item # 195291). The recall is due to a defect where the locking bar may not fully engage.
The affected units are identified by Lot Numbers 149710 and 615950. These products were distributed to facilities in numerous U.S. states, including New York, Indiana, Ohio, and Michigan, as well as internationally to countries such as Korea, China, Canada, and Australia.
This is a Class II recall. Healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers 149710 615950
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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