Dense Bone Drill WP 5x13 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 Dense Bone Drill WP 5x13 mm Single-Pat devices used to prepare bone in the upper and lower jaw before implant placement. The recall was initiated 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 have been 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 affected lot/code information is (01)07332747065459(10)73591 with catalog number 37098. The source does not specify a remedy 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)07332747065459(10)73591 Catalog# 37098
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.