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

Recall Z-1438-2023 — Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard It

U.S. FDA — Device Enforcement · United States · 2023-03-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1438-2023
Date of alert: 2023-03-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ROi CPS LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10194717114161

Reported risk: The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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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