FDA-Device2020-02-26Class II
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 repair can be used. The instruments are intended for both simple and advanced treatments.
Nobel Biocare Usa Llc
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.
Sold states
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.
Affected count
233 units
Manufactured in
22715 Savi Ranch Pkwy, Yorba Linda, CA, United States
Products
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 repair can be used. The instruments are intended for both simple and advanced treatments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2020Don't want to check this manually?
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