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Devices
Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlay
Model / Serial
OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Product Description
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Manufacturer
Matrix Surgical Holdings, LLC
1 Event
Recall of Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlay
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Manufacturer
Matrix Surgical Holdings, LLC
Manufacturer Address
Matrix Surgical Holdings, LLC, 4025 Welcome All Rd Sw Ste 120, Atlanta GA 30349-1876
Manufacturer Parent Company (2017)
Matrix Surgical Holdings Llc
Source
USFDA
Language
English
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