FDAApril 17, 2020device
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential presence of elevated endotoxin levels that exceed the specification limit
What to do
FDA enforcement status: Terminated
Brands named
biomet
UPCs
008803044517350088030445136000880304451346008803044513220088030445130800880304454859
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair2025-09-23
- FDAJuggerknot Mini Soft Anchors, Model/Catalog Number: 9120802025-09-09
- FDAJuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 1100273572024-10-21
- FDARingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-1652062024-05-17
- FDAVanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek l...2024-03-13
- FDABiolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-022023-11-02
- FDABiolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-012023-11-02
- FDAVitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System2023-10-16
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