Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling an Abutment Screw Retrieval Kit due to a problem in the packaging sealing process at the supplier. Because of this sealing defect, it cannot be guaranteed that the sterilized medical devices included in the kit remain sterile throughout their shelf-life. The recall affects 7 units 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 multiple European countries. The affected lot codes are (01)07332747083866(10)818727 and (01)07332747083866(10)818683, with Catalog# 37481.
The source document 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: 7 units Lot/code info: (01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.