Devices

Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.

Model / Serial
2956993 2956994
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Products were distributed worldwide.
Product Description
Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. 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 Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. 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)

Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Manufacturer

Regeneration Technologies, Inc.

Product is OPTEFORM¿ Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.