Vanguard Knee System recallZ-0496-2019 · Zimmer Biomet, Inc. · initiated Oct 22, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
FDA root cause category: Labeling mix-ups
What the company is doing
Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Recall details
- Recall number
- Z-0496-2019
- Status
- Terminated
- Initiated by the company
- Oct 22, 2018
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 8 units
- Product code
- JWH
- FDA submissions
- K023546, K113550
- Distribution
- AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Product description
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Code information (models, lots, serial numbers)
Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vanguard® Knee System 183126Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls3 reports
Product lines
Other devices under the same FDA submission
118 devices cleared under K023546, K113550 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vanguard® Knee System 183108Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls3 reports
- Vanguard® Knee System 189082Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls2 reports
- Vanguard® Knee System 183620Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
- Vanguard® Knee System 183106Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall4 reports
- Vanguard® Knee System 183104Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- Vanguard® Knee System 183122Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- Vanguard® Knee System 183124Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall2 reports
- Vanguard® Knee System 183622Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- Vanguard® Knee System 183742Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- Vanguard® Knee System 183112Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard® Knee System 189048Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard® Knee System 183744Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81472).
- Z-0495-2019 · TerminatedVanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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