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
This recall has been terminated (originally issued September 1, 2021).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- September 1, 2021
- Terminated
- February 16, 2023
- Recall Number
- Z-0114-2022
- Quantity
- 1 unit
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Distribution
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Lot / Code Info
Lot Number: 2013003419 Unique Identifier: 00840118103688
Root Cause
Packaging change control
Action Taken
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 FLOWERCS@FLOWERORTHO.COM