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TeDan Surgical Innovations LLC recalls D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start
Recalled March 25, 2020 · FDA recall Z-1503-2020 · TeDan Surgical Innovations
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. · FDA Class II
Units
49 boxes (245 individual screws)
Sold at
Worldwide.
Description
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.
Product
D-0012 3COR 12MM 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.
Manufacturer(s)
TeDan Surgical Innovations LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →