Food, drugs, devices › Integrity Implants Inc.
Device recall: LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N
FDA enforcement event 91071 is a device recall by Integrity Implants Inc. of Palm Beach Gardens, FL, initiated 3 Aug 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 23 Oct 2023. Initiation: voluntary: firm initiated. Integrity Implants Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integrity Implants Inc., Palm Beach Gardens, FL.
Reason for recall
"Potential for intraoperative screw head separation at weld location."
Distribution
"US distribution to California, Indiana, New York, Oklahoma, Washington DC"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0421-2023 | 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… | 50 screws | Class II | Terminated | 14 Dec 2022 |
Context
Other enforcement events for Integrity Implants Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Dec 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descripti | Device | Class II | 1 |
| 27 Jan 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw | Device | Class II | 3 |
| 27 Feb 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product | Device | Class II | 1 |
All 4 events for Integrity Implants Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for intraoperative screw head separation at weld location."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to California, Indiana, New York, Oklahoma, Washington DC"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.