Z-1309-2023 Class II Ongoing
FDA device recall Z-1309-2023 was initiated by Elekta Instrument AB on March 1, 2023 and is designated Class II. Reason for recall: The incorrect IFU was distributed with the devices. The recall status is ongoing. Affected quantity: 70 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 devices
Product Description
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.
Reason for Recall
The incorrect IFU was distributed with the devices.
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.
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.