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

Recall Z-3012-2017 — PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. 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.

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3012-2017
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

Reported risk: Devices are not consistent with Quality System Requirements.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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