Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Summary
The FDA issued a Class II for Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF by Medtronic Sofamor Danek USA Inc. Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. Thes.
Details
Source
Device Recall
External ID
Z-2121-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Lot/Code Info: UDI/DI 00763000465902, Lot Numbers: NM21K049
Quantity Affected: 10 units
Reason for Recall
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Distribution
US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-06
Company
Memphis, TN
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 165 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 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 (Medtronic Sofamor Danek USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Sofamor Danek USA Inc have FDA actions?
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2121-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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