CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report
Endoskeleton TC Interbody System recalled by Medtronic Sofamor Danek USA
Medtronic Sofamor Danek USA is recalling Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, distributed nationwide in the US. The recall was initiated on 17 Mar 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-1439-2021
- FDA event ID
- 87626
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2021
- FDA classified
- 20 Apr 2021
- Reported
- 28 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 17 Mar 2021 | Recall initiated by company | |
| 20 Apr 2021 | Classified by FDA | +34 days |
| 28 Apr 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
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Product as listed by the FDA
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small recalled?
Yes. Medtronic Sofamor Danek USA recalled Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small on 17 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1439-2021.
Why was it recalled?
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Which lots are affected?
GTIN 00191375013006, Lot Number TM0126527
Where was it sold?
US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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