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

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument — recall Z-1026-2022

U.S. FDA — Device Enforcement · United States · 2022-03-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1026-2022
Date of alert
2022-03-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
restor3d Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2022030005
Reported risk: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.