Recall Z-1698-2021— Flower Orthopedics Corporation
Class II · Terminated
Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2021-04-15, terminated 2021-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Flower Orthopedics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-15
- Terminated
- 2021-11-12
- Firm location
- Horsham, PA, United States
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.