Abutment Screw Retrieval Instrument RP/WP/6.0 - 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 r
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling 132 units of the Abutment Screw Retrieval Instrument RP/WP/6.0 (Catalog# 37504, Lot code 73562) worldwide, including throughout the United States and multiple countries across Europe, Asia, Africa, and the Americas. These instruments are used to retrieve broken abutment screws during dental implant procedures.
The recall was issued because a problem with the packaging sealing process at the supplier cannot guarantee that the sterilized medical devices remain sterile throughout their shelf-life. The record does not specify a remedy or what affected consumers should do.
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: 132 units Lot/code info: (01)07332747084092(10)73562 Catalog# 37504
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.