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Catalyft LS Expandable Interbody System recallZ-2119-2023 · Medtronic Sofamor Danek USA Inc · initiated Jun 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 06/06/2023 by UPS 2-day delivery. The notice explained the problem , risk, and requested the following actions be taken: "" For purchased inventory not consumed during a procedure: o Identify and quarantine any unused impacted product(s). Refer to the table above for impacted products. o Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " For Medtronic owned product at your facility: o Your Medtronic Sales Representative will locate and return this product. " Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. " This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."

Recall details

Recall number
Z-2119-2023
Status
Open, Classified
Initiated by the company
Jun 6, 2023
Posted by the FDA
Jul 10, 2023
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
25 units
Product code
OVD
FDA submissions
K212653
Distribution
US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

Product description

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

Code information (models, lots, serial numbers)

UDI/DI 00763000465889, Lot Numbers: NM21J039, NM21M026

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K212653 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92567).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page