FDA Device recall Z-2525-2020
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical…
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical… by Tedan Surgical Innovations, citing lack of pouch seal. Product is labelled as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2525-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-15 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tedan Surgical Innovations |
| Distribution | US |
Product
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Reason
Lack of pouch seal. Product is labelled as sterile.
Identifiers
| code_info | Product Code: D-0014 UDI Number: 00843059121742 Lot Number: 2018020801 2018080601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2525-2020%22
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