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Recall Observatory FDA recall evidence

Device 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

Z-1698-2021

April 15, 2021

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 87906
Status
Terminated
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-1698-2021

Official wording

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

Code information: Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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