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 replenish
Check against the official notice below — it lists the full affected range.
Integrity Implants Inc. is recalling 1,227 screws from its LineSider Spinal System, a pedicle screw system used in spinal fusion surgery. The screws have a potential defect in which the Upper Tulip Head component could separate from the Lower Tulip Head component due to weld failure, causing the entire Tulip Head to detach from the Screw Shank. The affected screws were distributed nationwide to 15 states and Puerto Rico, across multiple lot numbers and size variations ranging from 5.5mm to 7.5mm in diameter and 35mm to 60mm in length.
The record does not specify a remedy or instructions for what affected consumers should do 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: 1,227 screws Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.