Z-0418-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- January 27, 2022
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,227 screws
Product Description
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 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 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.
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 Pattern
Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
Code Information
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. 7.5mm x 55mm, Part Number: LS-N6SA7555, UDI: (01)00818613027907(10)02210132, Lot Number: 2210132. p. 7.5mm x 60mm, Part Number: LS-N6SA7560, UDI: (01)00818613027914(10)02210133, Lot Number: 2210133. q. 8.5mm x 35mm, Part Number: LS-N6SA8535, UDI: (01)00818613027938(10)02210134, Lot Number: 2210134. r. 8.5mm x 40mm, Part Number: LS-N6SA8540, UDI: (01)00818613027945(10)02210135, Lot Number: 2210135. s. 8.5mm x 45mm, Part Number: LS-N6SA8545, UDI: (01)00818613027952(10)02210136, Lot Number: 2210136. t. 8.5mm x 50mm, Part Number: LS-N6SA8550, UDI: (01)00818613027969(10)02210137, Lot Number: 2210137. u.8.5mm x 55mm, Part Number: LS-N6SA8555, UDI: (01)00818613027976(10)02210138, Lot Number: 2210138. v. 8.5mm x 60mm, Part Number: LS-N6SA8560, UDI: (01)00818613027983(10)03210142, Lot Number: 3210142.