PALLAS M/MAXIMIS MIS Screw 7 — Class II medical device recall Z-2922-2017
Terminated recall by Valorem Surgical LLC, reported 2017-08-16, distributed nationwide. Devices are not consistent with Quality System Requirements.
| Recall number | Z-2922-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valorem Surgical LLC, Chicago, IL, United States |
| Recall initiated | 2017-06-21 |
| Classified | 2017-08-10 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2018-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,225 units |
| Lot numbers | WNV120322, WNV120328 |
| Model numbers | P775-055 |
Product
PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. 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 for recall
Devices are not consistent with Quality System Requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2922-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.