Z-0421-2023Class II

LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model...

Name: Z-0421-2023 LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model...
Creator: Integrity Implants Inc.
Published: 2022-08-03
License: https://open.fda.gov/license/

Integrity Implants, Inc. / initiated 2022-08-03 / Terminated / root cause: manufacturing process

FDA source

Integrity Implants Inc. began a recall of LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle... on 2022-08-03. FDA classified it as Class II and gives the reason as "Potential for intraoperative screw head separation at weld location". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0421-2023
Classification: Class II
Status: Terminated
Initiated: 2022-08-03
Posted: 2022-12-05
Terminated: 2023-10-23
Recalling firm: Integrity Implants, Inc.
Product: LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Potential for intraoperative screw head separation at weld location.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form.
Quantity in commerce: 50 screws
Distribution: US distribution to California, Indiana, New York, Oklahoma, Washington DC
Product codes and lots: Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0421-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0421-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-05

Product code NKB

K203367Class IILineSider™ Spinal SystemIntegrity Implants, Inc. / cleared 2020-12-03

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)