FDAAugust 31, 2020device
CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
What to do
FDA enforcement status: Terminated
Brands named
biomet 3ibiomet
UPCs
00844868031154
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
- 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 -3, Item Number 00-8777-040-012023-11-02
- FDABiolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-022023-11-02
- FDAVitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System2023-10-16
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