Recall Z-1309-2023— Elekta Instrument AB

Name: FDA recall Z-1309-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-01

Class II · Ongoing

Class II FDA medical device recall by Elekta Instrument AB, initiated 2023-03-01. It names one FDA 510(k) clearance: K152558. 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.. Reason: The incorrect IFU was distributed with the devices..

Recalling firm: Elekta Instrument AB
Classification: Class II
Status: Ongoing
Initiated: 2023-03-01
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB·cleared 2016-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.