Full Dose CE Simplex P Single Bone Cement - Indicated recall
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Why was Full Dose CE Simplex P Single Bone Cement - Indicated recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 2085 units
- Distribution
- International distribution in the country of Turkey.
- Recall date
- December 28, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)