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
This recall has been terminated (originally issued April 15, 2021).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- April 15, 2021
- Terminated
- November 12, 2021
- Recall Number
- Z-1698-2021
- Quantity
- 47 units
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
Lot / Code Info
Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
Root Cause
Nonconforming Material/Component
Action Taken
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 FLOWERCS@FLOWERORTHO.COM "Acknowledgement and Product Replacement Forms (see attached)