FDAFDA · Food and drugs·Recall number Z-0214-2024
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Published November 8, 2023 · Recall initiated: October 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Corin Ltd
- Distributor
- US: MI, TX, IL
- Lot
- UDI/DI 05055343872505, Lot Number 532405.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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