FDA Device recall Z-2527-2020
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the ce…
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the ce… 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-2527-2020 |
| 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
PHANTOM CS 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: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101 |
|---|
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-2527-2020%22
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