Integrity Implants Inc. Recall 91070
Description: 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.
Integrity Implants Inc. Recall 91070 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0419-2023 |
| Event ID | 91070 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA. |
| Quantity | 1,702 screws |
| Recall 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. |
| Device Classification | 20221214 |
| Device 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. |
| Center Classification Date | 20221205 |
| Recall Initiation Date | 20220127 |
| Recalling Firm | Integrity Implants Inc. |
| Initial Notification | |
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