FDAFDA · Food and drugs·Recall number Z-1382-2017
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Published March 8, 2017 · Recall initiated: January 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeling. The packaging labeled as left mandible contained a right mandible.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Matrix Surgical Holdings, LLC
- Distributor
- Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
- Lot
- OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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