Product Wiki · Recalls · U.S. FDA — Device Enforcement

PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm — recall Z-2913-2017

U.S. FDA — Device Enforcement · United States · 2017-06-21 · Class II

As described by U.S. FDA — Device Enforcement: PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. 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.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2913-2017
Date of alert
2017-06-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Valorem Surgical LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution - US including CA and VA.
Reported risk: Devices are not consistent with Quality System Requirements.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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