Drill Tapered NP 3.5x8 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 Drill Tapered NP 3.5x8 mm Single-Pat guided drills used for preparing bone openings in surgical procedures. The recall affects 8 units distributed worldwide, including the United States and numerous countries across Europe, Asia, South America, Africa, and the Middle East. The devices are being recalled because a problem with the packaging sealing process at the supplier cannot guarantee that the sterilized medical devices remain sterile throughout their shelf-life.
The affected product has lot/code information (01)07332747065756(10)73466 and catalog number 37045. The source document does not specify what actions affected consumers should take in response to this recall.
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: 8 units Lot/code info: (01)07332747065756(10)73466 Catalog# 37045
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.