Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-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
- Recall Number
- Z-1440-2021
- Event Number
- 87626
- Firm
- Medtronic Sofamor Danek USA, Inc
- FEI Number
- 3003120897
- Product Code
- MAX
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- March 17, 2021
- Terminated
- May 3, 2023
- Address
- 4340 Swinnea Rd, Memphis, TN, 38118-6603
Description
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-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.
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.
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.
US Nationwide distribution.
11 devices