Screw Tap Tapered WP 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 has recalled Screw Tap Tapered WP Single guided drills (Twist Drills and Guided Tapered Drills) used for preparing bone sites for dental implants. The recall affects lot/code (01)07332747065701(10)73499, catalog number 37052, distributed worldwide including throughout the United States and numerous countries in North America, Europe, Asia, Australia, Africa, the Middle East, and South America.
The recall was issued because a problem in the packaging sealing process at the supplier cannot guarantee that the sterilized medical devices remain sterile throughout their shelf-life. The recall notice does not specify a remedy or instructions 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: None Lot/code info: (01)07332747065701(10)73499 Catalog# 37052
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.