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

Recall Z-0736-2023 — Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

U.S. FDA — Device Enforcement · United States · 2022-11-07 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0736-2023
Date of alert
2022-11-07
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327128772
Reported risk: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
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.