Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
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 bet…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Sofamor Danek USA Inc recalled Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 98102772… - a moderate-severity action.
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 98102772… was recalled by Medtronic Sofamor Danek USA Inc in July 19, 2023. Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic an…. Check the official notice for the remedy. Verify recall #Z-2122-2023 with the FDA Devices before acting.
The recall
Medtronic Sofamor Danek USA Inc issued this moderate-severity FDA Devices recall-There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic an….
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- July 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2122-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2122-2023) was formally reported on July 19, 2023, with the manufacturer initiating the action on June 6, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Sofamor Danek USA Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records list the affected scope as 8 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 units
Related Recalls
6
3 from same agency
Product description
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2122-2023 |
| Date reported | July 19, 2023 |
| Date initiated | June 6, 2023 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Firm location | Memphis, TN |
| Affected scope | 8 units |
| Distribution | US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2122-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 8 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2023. Severity: Moderate. Recall number: Z-2122-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2122-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 19, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.