Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling 45 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 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 defect in a medical device that could lead to injury, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 45 units of the XP-CR Tibial Tray- Interlok 59mm (Item # 195268). The recall is due to a defect where the locking bar may not fully engage.
The affected units were distributed across numerous U.S. states and several international regions, including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. Specific lot numbers associated with this recall include 004960, 262370, 130580, 004970, 130630, 130550, 130610, 130560, 130570, 004950, 130590, and 279210.
Healthcare providers and patients should check their inventory or medical records for these specific item and lot numbers. If the product is identified, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- XP- CR Tibial Tray- Interlok 59mm Item # 195268
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 45
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
- HighZimmer Biomet Recalls 75mm Tibial Tray Implants Due to Sizing Error
FDA (Devices) · 2018-06-20
- ModerateZimmer Universal Locking System Recalled for Incorrect Silk Screening
FDA (Devices) · 2015-10-14
- HighZimmer Recalls Distal Lateral Femoral Locking Plates Due to Sterility Failure
FDA (Devices) · 2014-01-08
- SevereZimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
FDA (Devices) · 2020-06-10
- HighZimmer Recalls Distal Lateral Femoral Locking Plates Due to Sterility Concerns
FDA (Devices) · 2014-01-08
- ModerateZimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
FDA (Devices) · 2016-01-20