International Medical Devices Database

Manufacturer Address
RTI Surgical, Inc., 11621 Research Cir, Alachua FL 32615-6825
Manufacturer Parent Company (2017)
RTI Surgical Inc
Source
USFDA
2 Events
- Recall of Device Recall OPTEFORM Allograft Paste
- Recall of Device Recall RTI Biologics BioSet IC RT Paste 2 cc

2 devices in the database

Device Recall OPTEFORM Allograft Paste

Model / Serial
Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed to Florida.
Product Description
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.

Device Recall RTI Biologics BioSet IC RT Paste 2 cc

Model / Serial
Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution: Colombia only
Product Description
RTI Biologics BioSet IC RT Paste 2 cc || Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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RTI Surgical, Inc.

2 devices in the database

Device Recall OPTEFORM Allograft Paste

Device Recall RTI Biologics BioSet IC RT Paste 2 cc