Devices

Device Recall OsseoFix System

Model / Serial
lot numbers 127726 and 191427
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
Product Description
Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. || The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.
Manufacturer
Implant Innovations, Inc.
1 Event
- Recall of Device Recall OsseoFix System

Manufacturer

Implant Innovations, Inc.

Manufacturer Address
Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410
Source
USFDA

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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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