FDAFDA · Food and drugs·Recall number 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 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Published June 9, 2021 · Recall initiated: April 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Flower Orthopedics Corporation
- Distributor
- US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
- Lot
- Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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