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.
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- March 17, 2021
- Terminated
- May 3, 2023
- Recall Number
- Z-1439-2021
- Quantity
- 11 devices
- Firm Location
- Memphis, TN
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
GTIN 00191375013006, Lot Number TM0126527
Root Cause
Packaging process control
Action Taken
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.
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