International Medical Devices Database

Manufacturer Address
Implantech Associates Inc, 6025 Nicolle St Ste A, Ventura CA 93003-7602
Manufacturer Parent Company (2017)
Implantech Associates Inc
Source
USFDA
2 Events
- Recall of Device Recall Terino Square chinStyle IIMedium
- Recall of Device Recall Gelzone Shoulder Sleeve

2 devices in the database

Device Recall Terino Square chinStyle IIMedium

Model / Serial
Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
Product Description
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. || To augment or reconstruct underdeveloped or traumatized mandibular region.

Device Recall Gelzone Shoulder Sleeve

Model / Serial
Catalog Number SLV634, Lot Number 852766.
Product Classification
Neurological Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
Product Description
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. || Product Usage: || To be used where limb support and/or elevation is considered necessary.

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)

Implantech Associates Inc

2 devices in the database

Device Recall Terino Square chinStyle IIMedium

Device Recall Gelzone Shoulder Sleeve