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

Recall Z-0644-2018 — Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

U.S. FDA — Device Enforcement · United States · 2018-01-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0644-2018
Date of alert: 2018-01-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Innovasis, Inc
Product category: device
Product type: Devices

Reported risk: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

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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