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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Howmedica Osteonics Corp.: 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.

Agency Publication Date: December 20, 2022
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Affected Products

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

UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021.

Lot Numbers:
GTIN
Product: Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot# GTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, which with expiration date on/after October 28, 2021

Lot Numbers:
GTIN

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91147
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Manufactured In: United States
Units Affected: 2 products (2085 units; 20 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.