FDAApril 1, 2016device
Various trauma and sports medicine instruments and implants. Passer.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
What to do
FDA enforcement status: Terminated
Brands named
biomet
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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