Z-1439-2021 Class II Terminated
FDA device recall Z-1439-2021 was initiated by Medtronic Sofamor Danek USA, Inc on March 17, 2021 and is designated Class II. 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. The recall status is terminated (terminated May 3, 2023). Affected quantity: 11 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- May 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 devices
Product Description
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.
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 Pattern
US Nationwide distribution.
Code Information
GTIN 00191375013006, Lot Number TM0126527