Drill Tapered 6.0 6x8 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 6.0 6x8 mm Single-Pat devices used to prepare bone in the upper and lower jaw before implant placement. The recall affects devices distributed worldwide, including across 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 devices with lot/code (01)07332747065541(10)73575 and catalog number 37089 are included in this recall.
The recall was initiated 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 source document does not specify a remedy or what affected consumers should do.
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)07332747065541(10)73575 Catalog# 37089
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.