Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 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 is recalling 526 units of Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm devices used to remove implants when the implant connection has been damaged. The recall was initiated because a problem with the packaging sealing process at the supplier cannot guarantee that these sterilized medical devices will remain 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, Macao, Colombia, Lebanon, and numerous European countries. The recalled lot numbers are (01)07332747083804(10)73601 and (01)07332747083804(10)73298, with catalog number 37475. 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: 526 units Lot/code info: (01)07332747083804(10)73601 (01)07332747083804(10)73298 Catalog# 37475
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.