Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
D-0012 3COR 12MM DISTRACTION SCREWS Recalled by TeDan Surgical Innovations LLC Due to The items identified for recall are labeled as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TeDan Surgical Innovations LLC directly.
Affected Products
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.
Quantity: 49 boxes (245 individual screws)
Why Was This Recalled?
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.
Where Was This Sold?
Worldwide.
About TeDan Surgical Innovations LLC
TeDan Surgical Innovations LLC has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report