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.
Check against the official notice below — it lists the full affected range.
Nobel Biocare Usa LLC is recalling Dense Bone Drill 6.0 6x16 mm devices used to prepare bone openings for dental implants. The recall affects 8 units distributed worldwide, including throughout the United States and in Canada, Australia, Japan, Brazil, South Africa, Russia, Taiwan, Hong Kong, India, China, Saudi Arabia, New Zealand, Macao, Colombia, Lebanon, and multiple European countries. The devices are being recalled because a problem with the packaging sealing process at the supplier means the sterilized devices cannot be guaranteed to remain sterile throughout their shelf-life.
The affected product has catalog number 37049 and lot/code information (01)07332747065756(10)73502. The recall notice does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE. Quantity: 8 units Lot/code info: (01)07332747065756(10)73502 Catalog# 37049
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.