Flower Orthopedics Corporation recalls T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to ins…

Recall date

April 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1698-2021

FDA classification

Class II

Brand / firm

Flower Orthopedics Corporation

Sold / distributed

US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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