The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2507-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 498 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 medical device (locking bar not fully engaging), which meets the criteria for a Severe rating.

Plain-English summary

Zimmer Biomet, Inc. is recalling 498 units of the XP-CR Tibial Tray - Interlok 69mm (Item # 195272). The recall was initiated because the locking bar on the device 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, Wyoming, Colorado, and Utah. The devices were also distributed to facilities in South Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.

Healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions. Consumers should not use these devices and should contact their healthcare provider if they have questions regarding their implant.

The recalled product

Product
XP-CR Tibial Tray - Interlok 69mm Item # 195272
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
498

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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

See all →

Same hazard · structural defect

See all →

Similar recalls