Devices

Product is 2.0 cc Opteform¿ RT. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.

Model / Serial
2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 2667987 2667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 2669636 2669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Products were distributed worldwide.
Product Description
Product is 2.0 cc Opteform¿ RT. 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 2.0 cc Opteform¿ RT. 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

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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.

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Product is 2.0 cc Opteform¿ RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Manufacturer

Regeneration Technologies, Inc.

Product is 2.0 cc Opteform¿ RT. Product is labeled in part: ''Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY***''.