Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Check against the official notice below — it lists the full affected range.
Nobel Biocare Usa Llc is recalling Drill Tapered WP 5x11.5 mm Single-Pat devices used to prepare bone in the upper and lower jaw before implant placement. The recall affects 59 units worldwide, including throughout the United States and numerous international markets, due to a packaging sealing problem at the supplier that prevents confirmation the sterilized devices remain sterile throughout their shelf-life. The affected lot code is (01)07332747065572(10)73451 with catalog number 37086.
The source record does not specify a remedy 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: 59 units Lot/code info: (01)07332747065572(10)73451 Catalog# 37086
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.