LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw sys
Summary
The FDA issued a Class II for LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulate by Integrity Implants Inc.. 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.
Details
Source
Device Recall
External ID
Z-0419-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product 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.
Lot/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.
Quantity Affected: 1,702 screws
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-27
Company
Palm Beach Gardens, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integrity Implants Inc. has 9 FDA actions in our database, including 5 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integrity Implants Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integrity Implants Inc. have FDA actions?
Integrity Implants Inc. has 9 FDA actions in our database, including 5 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0419-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29