Drill Tapered NP 3.5x10 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 Drill Tapered NP 3.5x10 mm Single-Pat devices used for preparing bone openings in dental implant procedures. The recall was issued 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 devices were 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, Macau, Colombia, Lebanon, and multiple European countries. The specific lot codes are (01)07332747065688(10)73415 and (01)07332747065688(10)73537 with catalog number 37075. The source record does not specify what remedy is available to 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. Lot/code info: (01)07332747065688(10)73415 (01)07332747065688(10)73537 Catalog# 37075
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.