FDA Device recall Z-1439-2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage:…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage:… by Medtronic Sofamor Danek Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1439-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-17 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
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.
Identifiers
| code_info | GTIN 00191375013006, Lot Number TM0126527 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Medtronic Sofamor Danek Usa
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa - Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM…
FDA Device · Class II · 2025-12-03 · Medtronic Sofamor Danek Usa - Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
All Medtronic Sofamor Danek Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1439-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.