FDA-Device2020-03-25Class II
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
TeDan Surgical Innovations LLC
Hazard
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Sold states
Worldwide.
Affected count
199 boxes (995 individual screws)
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2020Don't want to check this manually?
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