FDA-Device2017-03-08Class II
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Matrix Surgical Holdings, LLC
Hazard
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Sold states
Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Affected count
28
Manufactured in
4025 Welcome All Rd Sw Ste 120, N/A, Atlanta, GA, United States
Products
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2017Don't want to check this manually?
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