Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - 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 197 units of Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm devices used to remove dental implants when the implant connection has been damaged. The recall was issued because of a problem with the packaging sealing process at the supplier, which means the sterilility of these medical devices cannot be guaranteed throughout their shelf-life.
The affected devices were distributed worldwide, including throughout the US and Canada, Australia, Japan, Brazil, South Africa, Russia, Taiwan, Hong Kong, India, China, Saudi Arabia, New Zealand, Macao, Colombia, Lebanon, and multiple European countries. The specific lot code is (01)07332747083774(10)73303 with Catalog# 37472 & Tri-Chi. The source document 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: 197 units Lot/code info: (01)07332747083774(10)73303 Catalog# 37472 & Tri-Chi
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.