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

Recall Z-2248-2019 — Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

U.S. FDA — Device Enforcement · United States · 2019-06-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2248-2019
Date of alert
2019-06-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BioPro, Inc.
Product category
device
Product type
Devices
Reported risk: Manufacturing flaw in the sterile barrier system
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.

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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.