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Recall Observatory FDA recall evidence

Device product

Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

Z-1312-2020

March 14, 2019

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 84450
Status
Terminated
Classification
Class II
Quantity
59 units
Official record key
device-enforcement:Z-1312-2020

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)07332747065572(10)73451 Catalog# 37086

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.