Recall Z-0113-2022— Flower Orthopedics Corporation
Class II · Terminated
Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2021-09-01, terminated 2023-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any 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: DBK 027. Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure.
- Recalling firm
- Flower Orthopedics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-01
- Terminated
- 2023-02-16
- Firm location
- Horsham, PA, United States
Product description
Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any 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: DBK 027
Reason for recall
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Data sourced from openFDA. This site is unofficial and independent of the FDA.