International Medical Devices Database

Manufacturer Address
Tedan Surgical Innovations Llc, 12615 W Airport Blvd, Ste 200, Sugar Land TX 77478-6203
Manufacturer Parent Company (2017)
Tedan Surgical Innovations L.L.C.
Source
USFDA
1 Event
- Recall of Device Recall Sterile Distraction Screws of 3 different sizes

One device in the database

Device Recall Sterile Distraction Screws of 3 different sizes

Model / Serial
Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
Product Description
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand || Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.

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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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Tedan Surgical Innovations Llc

One device in the database

Device Recall Sterile Distraction Screws of 3 different sizes