The Recall Desk
SevereFDA (Devices)·Z-2535-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 99 units of Vanguard XP Tibial Tray 79 mm because the locking bar may not fully engage.

What this means for you

Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving medical devices are categorized as Severe (Score 4), particularly when structural defects like a locking bar failure are involved.

Plain-English summary

Zimmer Biomet, Inc. is recalling 99 units of the Vanguard XP Tibial Tray 79 mm (Item # 195252). The recall is being conducted because the locking bar on the device may not fully engage.

The affected units were distributed across numerous U.S. states and internationally to countries including Korea, China, Canada, Australia, Japan, and various European regions. Specific lot numbers associated with this recall include 332750, 833230, 515120, and others listed in the agency documentation.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.

The recalled product

Product
Vanguard XP Tibial Tray 79 mm Item # 195252
Affected units
99

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 →