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

Recall Z-0583-2021 — DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S

U.S. FDA — Device Enforcement · United States · 2020-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0583-2021
Date of alert
2020-11-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886982274014
Reported risk: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
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.