FDAFDA · Food and drugs·Recall number Z-2445-2024
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Published July 31, 2024 · Recall initiated: June 27, 2024
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
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- LINK BIO CORP
- Distributor
- US Nationwide distribution in the states of FL, GA, KS, OH, WI.
- Lot
- Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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