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Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm… recallZ-0114-2022 · Flower Orthopedics Corporation · initiated Sep 1, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging change control

What the company is doing

Coventus Orthopedic issued email communication on 9/01/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below. Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of affected product, Conventus Flower will ask that you return that affected kits. Conventus Flower will send replacement product as soon as we receive your completed Acknowledgement and Receipt Form. New DBK 020, DBK 024, DBK 027, or LSK 027 kits will be shipped to customers to replace affected product once the Acknowledgement and Receipt Form is received. Other Information: "Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]

Recall details

Recall number
Z-0114-2022
Status
Terminated
Initiated by the company
Sep 1, 2021
Recalling firm
Flower Orthopedics Corporation
Quantity
1 unit
Product code
HTW
Distribution
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Product description

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

Code information (models, lots, serial numbers)

Lot Number: 2013003419 Unique Identifier: 00840118103688

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 88669).

Sources and updates

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