Medtronic Sofamor Danek USA, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Medtronic Sofamor Danek USA, Inc
Lot Codes / Batch Numbers
GTIN 00191375013006, Lot Number TM0126527
Products Sold
GTIN 00191375013006, Lot Number TM0126527
Medtronic Sofamor Danek USA, Inc is recalling Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Prod due to The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small devic. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026