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Medtronic Sofamor Danek USA Inc Recall 92567

Description: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

Medtronic Sofamor Danek USA Inc Recall 92567 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2121-2023
Event ID92567
Event DescriptionMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Product TypeDevices
DistributionUS Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
Quantity10 units
Recall ReasonThere 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.
Device Classification20230719
Device Code InfoUDI/DI 00763000465902, Lot Numbers: NM21K049
Center Classification Date20230710
Recall Initiation Date20230606
Recalling FirmMedtronic Sofamor Danek USA Inc
Initial Notification Letter
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