Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect
Zimmer Biomet is recalling 322 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 medical device with a functional defect (locking bar not fully engaging) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 322 units of the XP-CR Tibial Tray - Interlok 63mm (Item # 195269). The recall was initiated because the locking bar on the device may not fully engage.
The affected devices were distributed across numerous U.S. states, including New York, Indiana, Ohio, Michigan, Georgia, South Carolina, Florida, Missouri, Wisconsin, Minnesota, North Dakota, South Dakota, Nebraska, New Jersey, Pennsylvania, Maryland, Illinois, Iowa, California, Virginia, North Carolina, Washington D.C., West Virginia, Arkansas, Alabama, Mississippi, Washington, Oregon, Idaho, Louisiana, Kansas, Tennessee, Massachusetts, Kentucky, Oklahoma, Texas, Connecticut, Arizona, Nevada, New Mexico, Montana, and Wyoming. The devices were also distributed internationally to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- XP-CR Tibial Tray - Interlok 63mm Item # 195269
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 322
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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