ENDOSKELETON TCS nanoLOCK Surface Technology recallZ-0086-2022 · Medtronic Sofamor Danek USA Inc · initiated Sep 2, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Engraving on implants may not match what is listed on the pouch labels.
FDA root cause category: Packaging change control
What the company is doing
A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to [email protected]. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.
Recall details
- Recall number
- Z-0086-2022
- Status
- Terminated
- Initiated by the company
- Sep 2, 2021
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 9 units
- Product code
- OVE
- FDA submissions
- K191565, K192018, K151596, K153122, K183557, K173535
- Distribution
- Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Product description
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Code information (models, lots, serial numbers)
Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1410-NMedtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
Product lines
Other devices under the same FDA submission
26 devices cleared under K191565, K192018, K151596, K153122, K183557, K173535 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ENDOSKELETON® TC nanoLOCK® Surface Technology 5146-1208-NMedtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- ENDOSKELETON® TC nanoLOCK® Surface Technology 5186-1608-NMedtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- ENDOSKELETON® TAS nanoLOCK® Surface Technology 2312-0212-NMedtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- ENDOSKELETON® TCS 5302-3514Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical5 reports
- ENDOSKELETON® TCS 5366-1410Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TCS 5302-3516Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TC nanoLOCK® Surface Technology 5146-1206-NMedtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, cervical2 reports
- ENDOSKELETON® TC 5166-1408Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, cervical1 report
- ENDOSKELETON® TCS 5301-3514Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5301-3516Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5301-3814Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5302-3518Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 88684).
- Z-0085-2022 · TerminatedEndoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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