Recall Z-0111-2022— 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 2.0 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. 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 2.0 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
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.