Drill Tapered WP 5x10 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 264 units of Drill Tapered WP 5x10 mm Single-Pat devices used to prepare bone in the upper and lower jaw prior to implant placement. The recall was initiated because a problem with the packaging sealing process at the supplier cannot guarantee that these sterilized medical devices remain sterile throughout their shelf-life. The affected devices were distributed worldwide, including throughout the United States and numerous countries in Canada, Australia, Japan, Brazil, South Africa, Russia, Taiwan, Hong Kong, India, China, Saudi Arabia, New Zealand, Macau, Colombia, Lebanon, and multiple European nations.
The affected product lot/code information includes (01)07332747065589(10)73287 and (01)07332747065589(10)73428 with catalog number 37085. The source document does not specify a remedy or recommended action for consumers who may have affected devices.
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: 264 units Lot/code info: (01)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.