FDA Device recall Z-1698-2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25…
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25… by Flower Orthopedics, citing cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1698-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-15 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Flower Orthopedics |
| Distribution | US |
Product
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Reason
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Identifiers
| code_info | Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853 |
|---|
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-1698-2021%22
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