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Nobel Biocare Usa Llc recalls Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices
Recalled February 26, 2020 · FDA recall Z-1324-2020 · 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
7 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 Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Manufacturer(s)
Nobel Biocare Usa Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →