Z-0111-2022 Class II Terminated
FDA device recall Z-0111-2022 was initiated by Flower Orthopedics Corporation on September 1, 2021 and is designated Class II. Reason for recall: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure The recall status is terminated (terminated February 16, 2023). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 1, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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
Distribution Pattern
Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
Code Information
Lot Number: 2013002721, 2013003589 Unique Identifier: 00840118101264