Endoskeleton TCS Interbody System implant engraving may not match pouch labels
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical implant device where engraving may not match pouch labels, creating a risk of wrong device implantation. Per the severity rubric, this is a risk-of-harm product without documented injury or hospitalization, scoring High (3).
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 9 units of Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology (Product Number 5366-1410-N, Lot A200510). The engraving on the implants may not match what is listed on the pouch labels.
This labeling discrepancy could result in the wrong device being implanted during surgery. The recalled units were distributed to facilities in California, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Washington, and West Virginia.
Patients and healthcare providers should verify that the correct device was implanted. Healthcare providers with questions about whether their devices are affected should contact Medtronic Sofamor Danek USA Inc.
The recalled product
- Product
- Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- labeling-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Number 5366-1410-N
- Lot A200510 GTIN 00191375018490
Distribution
Distributed in 14 states:
- CA
- MN
- MO
- NC
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- WA
- WV
Related recalls
Same category
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedline Lumbar Puncture Kit recalled for Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateMedela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
FDA (Devices) · 2026-07-08
- ModerateCRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach
FDA (Devices) · 2026-07-08