FDA Device recall Z-2980-2017
PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System
- FDA Device
- Class II
- terminated
- Published 2017-08-16
On 2017-08-16 the FDA classified a Class II recall of PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System by Valorem Surgical, citing devices are not consistent with Quality System Requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2980-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-21 |
| Published | 2017-08-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Valorem Surgical |
| Distribution | US |
Product
PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Reason
Devices are not consistent with Quality System Requirements.
Identifiers
| code_info | Catalog No. 0902-1004; Known Lot No. WNV120814, WNV111109. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2980-2017%22
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