Nobel Biocare Usa Llc recalls Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The G
Recalled Product
Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Hazard / Issue
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Issued by
FDA
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