DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Reported: February 7, 2024 Initiated: December 1, 2023 #Z-0920-2024
Product Description
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Reason for Recall
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.
Details
- 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.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611. Recalled by Howmedica Osteonics Corp..
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0920-2024.
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