Z-0418-2023Class II

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

Name: Z-0418-2023 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral...
Creator: Integrity Implants Inc.
Published: 2022-01-27
License: https://open.fda.gov/license/

Integrity Implants, Inc. / initiated 2022-01-27 / Terminated / root cause: design

FDA source

Integrity Implants Inc. began a recall of LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation... on 2022-01-27. FDA classified it as Class II and gives the reason as "Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0418-2023
Classification: Class II
Status: Terminated
Initiated: 2022-01-27
Posted: 2022-12-05
Terminated: 2023-10-23
Recalling firm: Integrity Implants, Inc.
Product: LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. 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. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Root cause tag: design
FDA root cause: Device Design
Action: Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
Quantity in commerce: 1,227 screws
Distribution: Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
Product codes and lots: a. 5.5mm x 35mm, Part Number: LS-N6SA5535, UDI: (01)00818613027716(10)02210117, lot Number: 2210117; Part Number: LS-N6SA7545, UDI: (01)00818613027884(10)02210130, Lot Number: 2210130. b. 5.5mm x 40mm, Part Number: LS-N6SA5540, UDI: (01)00818613027723(10)02210118, Lot Number: 2210118. c. 5.5mm x 45mm, Part Number: LS-N6SA5545, UDI: (01)00818613027730(10)02210119, Lot Number: 2210119. d. 5.5mm x 50mm, Part Number: LS-N6SA5550, UDI: (01)00818613027747(10)02210120, Lot Number: 2210120. e. 5.5mm x 55mm, Part Number: LS-N6SA5555, UDI: (01)00818613027754(10)02210121, Lot Number: 2210121. f. 6.5mm x 35mm, Part Number: LS-N6SA6535, UDI: (01)00818613027792(10)02210122, Lot Number: 2210122. g. 6.5mm x 40mm, Part Number: LS-N6SA6540, UDI: (01)00818613027808(10)02210123, Lot Number: 2210123. h. 6.5mm x 45mm, Part Number: LS-N6SA6545, UDI: (01)00818613027815(10)02210124, Lot Number: 2210124. i. 6.5mm x 50mm, Part Number: LS-N6SA6550, UDI: (01)00818613027822(10)02210125, Lot Number: 2210125. j. 6.5mm x 55mm, Part Number: LS-N6SA6555, UDI: (01)00818613027839(10)02210126, Lot Number: 2210126. k. 6.5mm x 60mm, Part Number: LS-N6SA6560, UDI: (01)00818613027846(10)02210127, Lot Number: 2210127. l. 7.5mm x 35mm, Part Number: LS-N6SA7535, UDI: (01)00818613027860(10)02210128, Lot Number: 2210128. m. 7.5mm x 40mm, Part Number: LS-N6SA7540, UDI: (01)00818613027877(10)02210129, Lot Number: 2210129. n. 7.5mm x 50mm, Part Number: LS-N6SA7550, UDI: (01)00818613027891(10)02210131, Lot Number: 2210131. o. 7.5mm x 55mm, Part Number: LS-N6SA7555, UDI: (01)00818613027907(10)02210132, Lot Number: 2210132. p. 7.5mm x 60mm, Part Number: LS-N6SA7560, UDI: (01)00818613027914(10)02210133, Lot Number: 2210133. q. 8.5mm x 35mm, Part Number: LS-N6SA8535, UDI: (01)00818613027938(10)02210134, Lot Number: 2210134. r. 8.5mm x 40mm, Part Number: LS-N6SA8540, UDI: (01)00818613027945(10)02210135, Lot Number: 2210135. s. 8.5mm x 45mm, Part Number: LS-N6SA8545, UDI: (01)00818613027952(10)02210136, Lot Number: 2210136. t. 8.5mm x 50mm, Part Number: LS-N6SA8550, UDI: (01)00818613027969(10)02210137, Lot Number: 2210137. u.8.5mm x 55mm, Part Number: LS-N6SA8555, UDI: (01)00818613027976(10)02210138, Lot Number: 2210138. v. 8.5mm x 60mm, Part Number: LS-N6SA8560, UDI: (01)00818613027983(10)03210142, Lot Number: 3210142.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-05
Z-0419-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-05
Z-0420-2023	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)