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Recall Observatory FDA recall evidence

Device product

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

Z-0111-2022

September 01, 2021

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 88669
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0111-2022

Official wording

Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Code information: Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264

Distribution pattern: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure