Zimmer Biomet Recalls Vanguard XP Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling Vanguard XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and internationally.
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 is classified as FDA Class II. The hazard involves a mechanical failure (locking bar not fully engaging) in an implanted medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, 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 Vanguard XP Tibial Tray 71 mm (Item # 195249) because the locking bar may not fully engage. 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 or where the probability of serious adverse health consequences is remote.
The recall includes specific lot numbers and units distributed across 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 to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers and patients should contact Zimmer Biomet for further information regarding the recall and potential replacement or repair options. Patients who have had this specific tibial tray implanted should consult with their orthopedic surgeon to discuss the implications of the locking bar issue.
The recalled product
- Product
- Vanguard XP Tibial Tray 71 mm Item # 195249
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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 →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateZimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error
FDA (Devices) · 2018-06-20
- HighZimmer Biomet Recalls Vanguard Knee Bearings Due to Packaging Mix-up
FDA (Devices) · 2018-07-04
- ModerateZimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error
FDA (Devices) · 2018-02-28
- HighVanguard Knee System Tibial Bearing Recalled for Manufacturing Damage
FDA (Devices) · 2024-05-01
- SevereZimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
FDA (Devices) · 2020-06-10
- ModerateZimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
FDA (Devices) · 2018-11-28