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

Recall Z-2153-2017 — Opteryx Variable Rescue Screw, Part #CP2214, UDI: +M711CP22140/$$801716012. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction

U.S. FDA — Device Enforcement · United States · 2017-05-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2153-2017
Date of alert: 2017-05-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Innovasis, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 801716012

Reported risk: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

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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