Implant 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 87 units of its Implant Retrieval Kit due to a packaging sealing problem at the supplier. Because of this defect in the sealing process, the sterilized medical devices included in the kit cannot be guaranteed to remain sterile throughout their shelf life.
The affected kits 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 recalled lot numbers are 857717, 857597, 857656, 818712, 818747, 818647, 857578, 857610, 857615, 857653, 857677, 857694, 857708, 857711, 857729, 857732, 818682, and 818811, all with catalog number 37470. 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: 87 units Lot/code info: 857717 (01)07332747083750(10)857717 28-Dec-2018 857597 (01)07332747083750(10)857597 31-Aug-2018 857656 (01)07332747083750(10)857656 22-Oct-2018 818712 (01)07332747083750(10)818712 9-Nov-2018 818747 (01)07332747083750(10)818747 9-Nov-2018 818647 (01)07332747083750(10)818647 10-Oct-2018 857578 (01)07332747083750(10)857578 23-Aug-2018 857610 (01)07332747083750(10)857610 10-Sep-2018 857615 (01)07332747083750(10)857615 13-Sep-2018 857653 (01)07332747083750(10)857653 10-Oct-2018 857677 (01)07332747083750(10)857677 7-Nov-2018 857694 (01)07332747083750(10)857694 3-Dec-2018 857708 (01)07332747083750(10)857708 14-Dec-2018 857711 (01)07332747083750(10)857711 20-Dec-2018 857729 (01)07332747083750(10)857729 8-Jan-2019 857732 (01)07332747083750(10)857732 15-Jan-2019 818682 (01)07332747083750(10)818682 5-Nov-2018 818811 (01)07332747083750(10)818811 18-Dec-2018 Catalog# 37470
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.