Devices

OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.

Model / Serial
2613431 2613432 2613433 2613434 2613435 2613436 2613437 2613438 2613439 2613440 2613901 2613902 2613903 2613904 2613905 2613906 2613907 2614881 2614882 2614883 2614884 2614885 2614886 2614887 2614888 2614889 2614890 2653106 2653107 2653108 2654250 2654251 2654252 2654253 2654254 2654255 2654256 2654257 2654258 2654259 2699840 2699841 2699842 2699843 2485231 2485232 2485233 2485234 2485235 2485236 2485237 2485238 2485239 2485240 2595521 2595522 2595921 2595922 2595923 2595924 2595925 2595926 2595927 2595928 2595929 2595930 2978531 2978532 2978533 2978534 2978535 2978536 2978537 2978538 2978539 2978540 2983613 2983614 2983615 2983616 2983831 2983832 2983842 2983843 2983844 2984801 2984802 2984803 2984804 2984805 2984806 2984807 2984808 2984809 2984810 2985721 2985722 2985723 2985724 2985725 2985726 2985727 2985728 2985729 2985730 2985791 2985792 2985793 2985794 2985795 2985796 2985797 2985798 2985799 2985800 2985911 2985912 2985913 2985914 2985915 2985916 2985917 2985918 2985919 2985920 2985991 2985992 2985993 2985994 2985995 2985996 2985997 2985998 2985999 2986000 2986841 2986842 2986843 2986844 2986845 2986846 2986847 2986848 2986849 2986850 2986861 2986862 2986863 2986864 2986865 2986866 2986867 2986868 2986869 2986870 2987907 2987908 2999921 2999922 2999923
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Products were distributed worldwide.
Product Description
OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Manufacturer
Regeneration Technologies, Inc.
1 Event
- Recall of OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Manufacturer

Regeneration Technologies, Inc.

Manufacturer Address
Regeneration Technologies, Inc., 11621 Research Circle, Alachua FL 32615
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Manufacturer

Regeneration Technologies, Inc.

OPTEFORM¿ RT Moldable Allograft of varying sizes. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.