The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2526-2019·Announced 2019-09-18

Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue

Zimmer Biomet is recalling 480 units of the XP-XP Tibial Tray 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 (locking bar not fully engaging) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 480 units of the XP-XP Tibial Tray - Interlok 63 mm (Item # 195751). The recall is being conducted because the locking bar on the device may not fully engage.

The affected products were distributed to facilities in 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 products were also distributed to facilities in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.

Healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions. Patients who have had these devices implanted should consult their healthcare provider regarding the recall.

The recalled product

Product
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
480

Distribution

Distributed in 44 states:

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 →

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