DUR PCA MTK REV INS RT Intended for knee replacement recall
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Why was DUR PCA MTK REV INS RT Intended for knee replacement recalled?
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
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?
GTIN: 04546540322951 Lot Numbers: 52177701
- Product
- DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
- Recalling firm
- Howmedica Osteonics Corp.
- Distribution
- Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)