FDA Device recall Z-2881-2017
PALLAS M/MAXIMIS MIS Poly Screw Driver 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 MIS Poly Screw Driver 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-2881-2017 |
| 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 MIS Poly Screw Driver 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. Unknown; Known Lot No. NHS160315. |
|---|
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-2881-2017%22
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