The Recall Desk
HighFDA (Devices)·Z-2518-2019·Announced 2019-09-18

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.

What this means for you

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
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.

See all 35 products in this recall →