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

Recall Z-0413-2013 — CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatmen

U.S. FDA — Device Enforcement · United States · 2012-09-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0413-2013
Date of alert: 2012-09-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Captiva Spine, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 06110093

Reported risk: Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking

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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