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Nobel Biocare Usa Llc recalls Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used
Recalled February 26, 2020 · FDA recall Z-1325-2020 · Nobel Biocare Usa
Hazard
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. · FDA Class II
Units
132 units
Sold at
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.
Description
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.
Product
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 repair can be used. The instruments are intended for both simple and advanced treatments.
Manufacturer(s)
Nobel Biocare Usa Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →