Flower Orthopedics Corporation Recall 87906
Description: 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
Flower Orthopedics Corporation Recall 87906 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1698-2021 |
| Event ID | 87906 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA. |
| Quantity | 47 units |
| Recall 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 |
| Device Classification | 20210609 |
| Device Code Info | Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853 |
| Center Classification Date | 20210601 |
| Recall Initiation Date | 20210415 |
| Recalling Firm | Flower Orthopedics Corporation |
| Initial Notification | |
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