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
Check against the official notice below — it lists the full affected range.
Flower Orthopedics Corporation is recalling T25 Cannulated Screwdrivers (model CSD 025) that were packaged in Guide Wire Kits (GWK 300). These screwdrivers are designed to insert screws with T25 driving features. The screwdrivers may break at the driver tip along the shaft near the handle, which can extend surgery time and require additional x-rays to identify fragments from the breakage. A total of 47 units were distributed nationwide across Arizona, Colorado, Florida, Georgia, Illinois, Indiana, North Carolina, Pennsylvania, and Virginia.
The affected products are identified by lot numbers 2003320898, 1810220041, 1802220008, 1802220005, and 1711220035, with UDI 00840118110853. The source document does not specify a remedy or what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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. Quantity: 47 units Lot/code info: Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.