Agency classClass IIOur severity:Severe FDA (Devices)·Z-2506-2019·Announced 2019-09-18

Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Issue

Zimmer Biomet is recalling 567 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a load-bearing orthopedic implant, which poses a significant risk of injury or device failure.

Plain-English summary

Zimmer Biomet, Inc. is recalling 567 units of the XP-CR Tibial Tray - Interlok 67mm (Item # 195271). The recall is due to a defect where the locking bar may not fully engage.

The affected devices 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 devices were also distributed internationally to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.

Healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement. Consumers who have had this device implanted should contact their healthcare provider for evaluation.

The recalled product

Product: XP-CR Tibial Tray - Interlok 67mm Item # 195271
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
device-failure
Affected units: 567

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