T25 Cannulated Screwdrivers (CSD 025) packaged in Guide… recallZ-1698-2021 · Flower Orthopedics Corporation · initiated Apr 15, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
Flower Orthopedic issued Urgent Recall Information via email on 4/15/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below and quarantine immediately. Next, please complete and return the attached Acknowledgement and Receipt Form as soon as possible. Flower Orthopedics is initiating shipment of replacement product for delivery Friday April 16. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected] "Acknowledgement and Product Replacement Forms (see attached)
Recall details
- Recall number
- Z-1698-2021
- Status
- Terminated
- Initiated by the company
- Apr 15, 2021
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 47 units
- Product code
- HXX
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
Product 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
Code information (models, lots, serial numbers)
Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Guide Wire Kit, 5.5/6.5/7.3 Cannulated Screws GWK 300Flower Orthopedics Corporation · Passer, Wire, Orthopedic1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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