FDAJanuary 27, 2022device
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 replenishm...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
integrity implantsintegrity
UPCs
008186130225680081861302257500818613022582008186130225990081861302260500818613022643008186130226500081861302266700818613022674008186130226810081861302269800818613022711
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.2025-08-26
- FDAOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.2025-08-26
- FDAOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.2025-08-26
- FDAIMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: IL...2025-07-30
- FDAThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as veri...2025-05-01
- FDABrand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusio...2024-12-20
- FDARAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 630262024-02-01
- FDATo the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 630262024-02-01
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