FDA Device recall Z-0111-2022
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 t…
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of 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 t… by Flower Orthopedics, citing drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0111-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-01 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Flower Orthopedics |
| Distribution | AZ, CA, CO, FL, IL, IN, NV, OH, TX, VA |
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
Identifiers
| code_info | Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0111-2022%22
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