—#201712

Product

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

FDA product code: OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K212653
Affected lot / code info: UDI/DI 00763000465919, Lot Numbers: NM21K050, NM22B007

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

Timeline

Recall initiated: 2023-06-06
Posted by FDA: 2023-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.