Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

PALLAS M/MAXIMIS 60mm MIS Rod. 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.

FDA Recall Z-2887-2017 · Posted None

Recalling FirmValorem Surgical LLC
Recall StatusTerminated
Product CodeMNI
Date Initiated2017-06-21
Date Terminated2018-11-27
Product Quantity2,225 units total

Reason for Recall

Devices are not consistent with Quality System Requirements.

Firm Action

Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at [email protected] or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to [email protected]

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution - US including CA and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑