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 replenishment
Check against the official notice below — it lists the full affected range.
Integrity Implants Inc. is recalling 1,702 spinal pedicle screws from the LineSider Spinal System due to a potential defect in the weld joining the Upper Tulip Head component to the Lower Tulip Head component. If the weld separates, the Tulip Head could separate from the Screw Shank. The affected screws were distributed nationwide to 15 states and Puerto Rico. The recalled products include multiple sizes and lengths of 5.5mm, 6.5mm, and 7.5mm screws with specific lot numbers ranging from 2210139 to 2210152 (and related variants).
The recall record does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA. Quantity: 1,702 screws Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.