Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

FDA Device Recall #Z-1798-2015 — Class II — April 22, 2015

Recall Summary

Recall Number Z-1798-2015
Classification Class II — Moderate risk
Date Initiated April 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 27

Product Description

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Reason for Recall

The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.

Distribution Pattern

Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.

Lot / Code Information

Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270

Other Recalls from Biomet, Inc.

Recall # Classification Product Date
Z-0212-2026 Class II BIOMET ZipTight, Acute AC Joint Implant, Single... Sep 23, 2025
Z-2619-2025 Class II Juggerknot Mini Soft Anchors, Model/Catalog Num... Sep 9, 2025
Z-0477-2025 Class II JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model nu... Oct 21, 2024
Z-2179-2024 Class II RingLoc Bi-Polar Hip System Acetabular Cup, 41 ... May 17, 2024
Z-1607-2024 Class II Vanguard Knee System AS Tibial Bearing / DCM Ar... Mar 13, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.