Drill Tapered NP 3.5x11.5 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 473 units of Drill Tapered NP 3.5x11.5 mm Single-Pat guided drills used for preparing bone openings in dental implant procedures. The recall was issued because a packaging sealing problem at the supplier means the sterilized devices cannot be guaranteed to remain sterile throughout their shelf-life. The affected devices have lot/code information (01)07332747065671(10)73280 with catalog number 37076 and were distributed worldwide, including throughout the United States and in Canada, Australia, Japan, Brazil, and numerous other countries.
The recall notice does not specify a remedy or corrective action for affected 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: 473 units Lot/code info: (01)07332747065671(10)73280 Catalog# 37076
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.