Z-1309-2023Class II

Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1)...

Name: Z-1309-2023 Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1)...
Creator: Elekta Instrument AB
Published: 2023-03-01
License: https://open.fda.gov/license/

Elekta Instrument AB / initiated 2023-03-01 / Open, Classified / root cause: labeling and UDI

FDA source

Elekta Instrument AB began a recall of Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion... on 2023-03-01. FDA classified it as Class II and gives the reason as "The incorrect IFU was distributed with the devices". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1309-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-01
Posted: 2023-03-30
Recalling firm: Elekta Instrument AB
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The incorrect IFU was distributed with the devices.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm issued a Field Safety Notification dated February 2023 on 3/1/2023 via email. The notification describes the problem, lists the part numbers involved, the clinical impact, and recommended user actions also letting them know the correct IFU will be shipped to all affected customers. The recommended user actions include posting the notice in a place accessible to all users until this action is closed and advising the appropriate personnel working with the product on the content of the letter. The consignee is informed that Elekta will provide customers with the correct IFU. An Acknowledgement Form is enclosed to acknowledge receipt of the notification to Elekta Care Community or complete the form and return it to Elekta no later than within 30 days. The consignee is to provide the device serial number and location or site and sign the form that they had read and understand the notice. On 3/2/2023, the correct IFU version was released to all internal service managers who will ensure all customers received the corrected version.
Quantity in commerce: 70 devices
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code HAW

K152558Class IILeksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB / cleared 2016-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)