Drill Tapered RP 4.3x13 mm 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 is recalling 154 units of Drill Tapered RP 4.3x13 mm Single-Pat guided drills, which are surgical devices used to prepare bone sites for implants. The recall was issued because a problem with the packaging sealing process at the supplier cannot guarantee that these sterilized devices remained sterile throughout their shelf life.
The affected devices were 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, Macau, Colombia, Lebanon, and various European countries. The specific lot code is (01)07332747065619(10)73274 with Catalog# 37082. 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: 154 units Lot/code info: (01)07332747065619(10)73274 Catalog# 37082
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.