Z-1698-2021 Class II Terminated

Recalled by Flower Orthopedics Corporation — Horsham, PA

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
April 15, 2021
Termination Date
November 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47 units

Product Description

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 Pattern

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

Code Information

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