LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N
Summary
The FDA issued a Class II for LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual by Integrity Implants Inc.. Reason: Potential for intraoperative screw head separation at weld location..
Details
Source
Device Recall
External ID
Z-0421-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product Description
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. 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. Used in spinal fixation surgery.
Lot/Code Info: Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Quantity Affected: 50 screws
Reason for Recall
Potential for intraoperative screw head separation at weld location.
Distribution
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-03
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-0421-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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