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

Recall Z-0622-2016 — UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined

U.S. FDA — Device Enforcement · United States · 2015-11-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0622-2016
Date of alert: 2015-11-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OrthoPediatrics Corp
Product category: device
Product type: Devices

Reported risk: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.

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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