FDA recall Z-1698-2021

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 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.

Key facts

Status

Terminated

Initiation date

2021-04-15

Report date

2021-06-09

Termination date

2021-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2021