Agency classClass IIOur severity:High FDA (Devices)·Z-2519-2019·Announced 2019-09-18

Zimmer Biomet Recalls XP-XP Tibial Trays Due to Locking Bar Defect

Zimmer Biomet is recalling specific XP-XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and several international regions.

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 device (locking bar not fully engaging) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer Biomet, Inc. is recalling the XP-XP Tibial Tray - Interlok 79 mm (Item # 195758). The recall is due to a defect where the locking bar may not fully engage. This issue could affect the stability of the implant.

The affected product was distributed 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, Wyoming, Colorado, and Utah. The product was also distributed in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.

Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed. The source text does not specify the number of affected units or report any illnesses or injuries associated with this recall.

The recalled product

Product: XP-XP Tibial Tray - Interlok 79 mm Item # 195758
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
implant-failure

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 →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · structural defect