FDAApril 17, 2020device
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Kn...
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
050192795152260501927951524005019279515301050192795154930501927951564605019279999453050192799994600501927999947705019279786213
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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