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Recall Observatory FDA recall evidence

Device 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.

Z-1325-2020

March 14, 2019

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 84450
Status
Terminated
Classification
Class II
Quantity
132 units
Official record key
device-enforcement:Z-1325-2020

Official wording

Reason: 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.

Code information: (01)07332747084092(10)73562 Catalog# 37504

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.