FDAMarch 13, 2024device
Vanguard 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
What to do
FDA enforcement status: Ongoing
Brands named
biomet
UPCs
00880304436954
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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
- 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
- FDACompress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 1784082023-10-09
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