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

Recall Z-2135-2024 — CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (

U.S. FDA — Device Enforcement · United States · 2024-05-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2135-2024
Date of alert
2024-05-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Blue Belt Technologies, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00885556755068
Reported risk: CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.