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

Recall Z-2677-2014 — Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatme

U.S. FDA — Device Enforcement · United States · 2014-04-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2677-2014
Date of alert: 2014-04-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Genesys Orthopedics Systems, LLC
Product category: device
Product type: Devices

Reported risk: The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.

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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