Devices

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.
Manufacturer
RTI Surgical, Inc.
1 Event
- Recall of Device Recall OPTEFORM Allograft Paste

Manufacturer

RTI Surgical, Inc.

Manufacturer Address
RTI Surgical, Inc., 11621 Research Cir, Alachua FL 32615-6825
Manufacturer Parent Company (2017)
RTI Surgical Inc
Source
USFDA

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