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Recall Observatory FDA recall evidence

Device product

Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

Z-1309-2020

March 14, 2019

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 84450
Status
Terminated
Classification
Class II
Quantity
260 units
Official record key
device-enforcement:Z-1309-2020

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)07332747065626(10)73474 (01)07332747065626(10)73369 Catalog# 37081

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.