Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Cata
Summary
The FDA issued a Class III for Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prosth by Howmedica Osteonics Corp.. Reason: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, .
Details
Source
Device Recall
External ID
Z-0736-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Lot/Code Info: 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.
Quantity Affected: 2085 units
Reason for Recall
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.
Distribution
International distribution in the country of Turkey.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-07
Company
Mahwah, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 404 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0736-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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