Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 384 units of the XP-XP Tibial Tray - Interlok 83 mm 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. The hazard involves a structural component (locking bar) not fully engaging in a load-bearing 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 384 units of the XP-XP Tibial Tray - Interlok 83 mm (Item # 195759). The recall is due to a defect where the locking bar is not fully engaging.
The affected product was distributed to facilities in numerous US 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 product was also distributed to facilities in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers should stop using the affected tibial trays and contact Zimmer Biomet for further instructions. Patients who have had this specific device implanted should consult their orthopedic surgeon to determine if any follow-up care is necessary.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 83 mm Item # 195759
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 384
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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