CLASS II Device recall · Reported 20 Oct 2021 · FDA Enforcement Report
Endoskeleton" TCS Interbody System recalled
Medtronic Sofamor Danek USA is recalling Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6, distributed in 14 states. The recall was initiated on 2 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0086-2022
- FDA event ID
- 88684
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Sep 2021
- FDA classified
- 12 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 2 Sep 2021 | Recall initiated by company | |
| 12 Oct 2021 | Classified by FDA | +40 days |
| 20 Oct 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Engraving on implants may not match what is listed on the pouch labels.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Where it was distributed
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
CaliforniaMinnesotaMissouriNorth CarolinaNevadaNew YorkOhioOklahomaOregonPennsylvaniaSouth CarolinaSouth DakotaWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Engraving on implants may not match what is listed on the pouch labels.
Which lots are affected?
Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
Where was it sold?
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88684| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Endoskeleton" TAS Interbody System recalled | Medtronic Sofamor Danek USA | Device Malfunction | 14 states |
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