Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repa
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling 233 units of Abutment Screw Retrieval Instrument 3.0/NP worldwide, including distribution in the United States and numerous countries across Europe, Asia, the Americas, Africa, and the Middle East. The recall affects units with lot/code information (01)07332747084085(10)73585 and (01)07332747084085(10)73430, with catalog number 37503.
The recall was issued because a problem with the packaging sealing process at the supplier cannot guarantee that the sterilized medical devices remain sterile during their shelf-life. 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: 233 units Lot/code info: (01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.