Device product
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
Z-1309-2023
Product summary
- Event
- Event 91780
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 devices
- Official record key
device-enforcement:Z-1309-2023
Official wording
Reason: The incorrect IFU was distributed with the devices.
Code information: UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.
Distribution pattern: US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution.
Derived failure modes
-
Unknown
The incorrect IFU was distributed with the devices.