Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF… Recall
Issued July 19, 2023 · Medtronic Sofamor Danek USA Inc
In July 2023, Medtronic Sofamor Danek USA Inc recalled the Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Sofamor Danek USA Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Medtronic Sofamor Danek USA Inc
- Category
- Health
- Recall date
- July 19, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
- Recall number
- FDA-Z-2121-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Sofamor Danek USA Inc has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.