Recall Z-1440-2021— 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 3 FDA 510(k) clearances: K192018, K183557, K141953. 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.. 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
3 on FDA's record- K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
- K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
- K141953 — ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
K-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, 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.
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.