Medtronic Sofamor Danek USA, Inc Recall 87626
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.
Medtronic Sofamor Danek USA, Inc Recall 87626 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1440-2021 |
| Event ID | 87626 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 11 devices |
| Recall 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. |
| Device Classification | 20210428 |
| Device Code Info | GTIN 00191375013167, Lot Number TM0126572 |
| Center Classification Date | 20210420 |
| Recall Initiation Date | 20210317 |
| Recalling Firm | Medtronic Sofamor Danek USA, Inc |
| Initial Notification | Letter |
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