medical Class II Updated 2020-02-26

Nobel Biocare Usa Llc recalls Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The

Recalled Product

Dense Bone Drill 6.0 6x16 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

Distribution: Nationwide (United States)
Lot/Code Info: (01)07332747065756(10)73502 Catalog# 37049
View official government recall

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