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Recall Observatory FDA recall evidence

Device product

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

Z-1649-2022

December 28, 2020

Class II

Product summary

Firm
New Standard Device Inc
Event
Event 90670
Status
Ongoing
Classification
Class II
Quantity
410 total devices
Official record key
device-enforcement:Z-1649-2022

Official wording

Reason: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Code information: Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD

Distribution pattern: U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.