Z-2119-2023Class II

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

Name: Z-2119-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Creator: Medtronic Sofamor Danek USA Inc
Published: 2023-06-06
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2023-06-06 / Open, Classified

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant on 2023-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2119-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-06
Posted: 2023-07-10
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
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.
FDA root cause: Under Investigation by firm
Action: 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."
Quantity in commerce: 25 units
Distribution: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
Product codes and lots: UDI/DI 00763000465889, Lot Numbers: NM21J039, NM21M026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2119-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2117-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2118-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2119-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2120-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2121-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2122-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2123-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10

Product code OVD

K212653Class IICatalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. / cleared 2021-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)