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 45m
Hazard
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.
What You Should Do
Remedy
Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
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Products
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
- Brand
- Integrity Implants Inc.
- UPC
- 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.
Units Affected
1,227 screws