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Matrix Surgical Holdings, LLC recalls OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Recalled March 8, 2017 · FDA recall Z-1382-2017 · Matrix Surgical Holdings
Hazard
Mislabeling. The packaging labeled as left mandible contained a right mandible. · FDA Class II
Units
28
Sold at
Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Description
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Product
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Manufacturer(s)
Matrix Surgical Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →