Recall Z-1439-2021— Medtronic Sofamor Danek USA, Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA, Inc, initiated 2021-03-17, terminated 2023-05-03. It names one FDA 510(k) clearance: K192018. 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.. Reason: 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..
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-17
- Terminated
- 2023-05-03
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.