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Terminated

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

FDA Recall Z-1698-2021 · Posted None

Recalling FirmFlower Orthopedics Corporation
Recall StatusTerminated
Product CodeHXX
Date Initiated2021-04-15
Date Terminated2021-11-12
Product Quantity47 units

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

Firm Action

Flower Orthopedic issued Urgent Recall Information via email on 4/15/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below and quarantine immediately. Next, please complete and return the attached Acknowledgement and Receipt Form as soon as possible. Flower Orthopedics is initiating shipment of replacement product for delivery Friday April 16. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected] "Acknowledgement and Product Replacement Forms (see attached)

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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