CLASS II Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
LineSider Spinal System, Non-mod Standard - Dual Lead, Cannulated recalled
Integrity Implants is recalling LineSider Spinal System, Non-mod Standard - Dual Lead, Cannulated, distributed nationwide in the US. The recall was initiated on 27 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0419-2023
- FDA event ID
- 91070
- Recalling firm
- Integrity Implants, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jan 2022
- FDA classified
- 5 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Jan 2022 | Recall initiated by company | |
| 5 Dec 2022 | Classified by FDA | +312 days |
| 14 Dec 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, 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 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.
Where it was distributed
Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
Nationwide ArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaIllinoisIndianaLouisianaMassachusettsMinnesotaNew JerseyOklahomaPuerto RicoTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
a. 5.5mm x 35mm, Part Number: LS-N6SG5535, UDI: (01)00818613022568(10)02210139, lot Number: 2210139. b. 5.5mm x 40mm, Part Number: LS-N6SG5540, UDI: (01)00818613022575(10)02210140, Lot Number: 2210140. c. 5.5mm x 45mm, Part Number: LS-N6SG5545, UDI: ((01)00818613022582(10)02210141, Lot Number: 2210141. d. 5.5mm x 50mm, Part Number: LS-N6SG5550, UDI: (01)00818613022599(10)02210142, Lot Number: 2210142. e. 5.5mm x 55mm, Part Number: LS-N6SG5555, UDI: (01)00818613022605(10)02210143, Lot Number: 2210143. f. 6.5mm x 35mm, Part Number: LS-N6SG6535, UDI: (01)00818613022643(10)02210144, Lot Number: 2210144. g. 6.5mm x 40mm, Part Number: LS-N6SG6540, UDI: (01)00818613022650(10)02210145, Lot Number: 2210145. h. 6.5mm x 45mm, Part Number: LS-N6SG6545, UDI: (01)00818613022667(10)02210146, Lot Number: 2210146, UDI: (01)00818613022667(10)02210146-1, Lot Number: 02210146-1. i. 6.5mm x 50mm, Part Number: LS-N6SG6550, UDI: (01)00818613022674(10)02210147, Lot Number: 2210147. j. 6.5mm x 55mm, Part Number: LS-N6SG6555, UDI: (01)00818613022681(10)02210148, Lot Number: 2210148. k. 6.5mm x 60mm, Part Number: LS-N6SG6560, UDI: (01)00818613022698(10)02210149, Lot Number: 2210149. l. 7.5mm x 35mm, Part Number: LS-N6SG7535, UDI: (01)00818613022711(10)02210150, Lot Number: 2210150. m. 7.5mm x 40mm, Part Number: LS-N6SG7540, UDI: (01)00818613022735(10)02210152, Lot Number: 2210151. n. 7.5mm x 45mm, Part Number: LS-N6SG7545, UDI: (01)00818613027891(10)02210131, Lot Number: 2210152. o. 7.5mm x 50mm, Part Number: LS-N6SG7550, UDI: (01)00818613022742(10)02210153, Lot Number: 2210153. p. 7.5mm x 55mm, Part Number: LS-N6SG7555, UDI: (01)00818613022759(10)02210154, Lot Number: 2210154. q. 7.5mm x 60mm, Part Number: LS-N6SG7560, UDI: (01)00818613022766(10)02210155, Lot Number: 2210155. r. 8.5mm x 35mm, Part Number: LS-N6SG8535, UDI: (01)00818613022780(10)02210156, Lot Number: 2210156. s. 8.5mm x 40mm, Part Number: LS-N6SG8540, UDI: (01)00818613022797(10)02210157, Lot Number: 2210157. t. 8.5mm x 45mm, Part Number: LS-N6SG8545, UDI: (01)00818613022803(10)02210158, Lot Number: 2210158. u. 8.5mm x 50mm, Part Number: LS-N6SG8550, UDI: (01)00818613022810(10)02210159, Lot Number: 2210159. v.8.5mm x 55mm, Part Number: LS-N6SG8555, UDI: (01)00818613022827(10)02210160, Lot Number: 2210160. w. 8.5mm x 60mm, Part Number: LS-N6SG8560, UDI: (01)00818613022834(10)02210161, Lot Number: 2210161.
Where was it sold?
Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 91070| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LineSider Spinal System, Non-mod MIS - Dual Lead, Cannulated recalled | Integrity Implants | Other | Nationwide | |
| CLASS II | LineSider Spinal System, Non-mod Standard - Dual Lead recalled | Integrity Implants | Other | Nationwide |
More recalls from Integrity Implants
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | N/A Repeater Bone Tamp recalled by Integrity Implants | Integrity Implants | Device Malfunction | Nationwide |
| Device | CLASS II | LineSider Spinal System, Non-mod Standard - Dual Lead recalled | Integrity Implants | Other | Nationwide |
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| Device | CLASS II | LineSider Spinal System, Non-mod MIS - Dual Lead, Cannulated recalled | Integrity Implants | Other | Nationwide |
| Device | CLASS II | FlareHawk Interbody Fusion System recalled by Integrity Implants | Integrity Implants | Other | Nationwide |
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