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Recall Observatory FDA recall evidence

Device product

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

Z-0114-2022

September 01, 2021

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 88669
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0114-2022

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: 2013003419 Unique Identifier: 00840118103688

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

Field note

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