Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC has recalled 31 units of the Implant Retrieval Instrument CC 3.0 31 mm, which is used to remove dental implants when the implant connection has been damaged. The recall affects devices 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 numerous European countries. The affected lot is identified by code (01)07332747083781(10)73306 with catalog number 37473.
The recall was initiated because a problem with the packaging sealing process at the device supplier cannot guarantee that the sterilized medical devices remain sterile throughout their shelf-life. The FDA record does not specify a remedy or instructions 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: 31 units Lot/code info: (01)07332747083781(10)73306 Catalog# 37473
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.