FDA Enforcement Class II Terminated

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.

Recall: Z-0419-2023 · Reported December 14, 2022

Enforcement

Recall Number: Z-0419-2023
Event ID: 91070
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Integrity Implants Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: E-Mail
Report Date: December 14, 2022
Initiation Date: January 27, 2022
Classification Date: December 5, 2022
Termination Date: October 23, 2023
Address: 354 Hiatt Drive, N/A, Palm Beach Gardens, FL, 33418, United States

Description

Reason

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.

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 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.

Distribution

Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.

Quantity

1,702 screws