510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1440-2021Class II

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product...

Medtronic Sofamor Danek USA Inc / initiated 2021-03-17 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Medtronic Sofamor Danek USA, Inc began a recall of Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1440-2021
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Sofamor Danek USA Inc
Product
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.
Product code
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
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.
Quantity in commerce
11 devices
Distribution
US Nationwide distribution.
Product codes and lots
GTIN 00191375013167, Lot Number TM0126572

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1440-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1439-2021Class IITerminatedVoluntary: Firm initiated
Z-1440-2021Class IITerminatedVoluntary: Firm initiated