Device 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
Z-0111-2022
Product summary
- Event
- Event 88669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0111-2022
Official wording
Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Code information: Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264
Distribution pattern: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Derived failure modes
-
Unknown
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure