FDAFDA · Food and drugs·Recall number Z-0086-2022
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Published October 20, 2021 · Recall initiated: September 2, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Engraving on implants may not match what is listed on the pouch labels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
- Lot
- Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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