Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PHANTOM CS DISTRACTION SCREW Recalled by TeDan Surgical Innovations LLC Due to Lack of pouch seal. Product is labelled 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
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Quantity: 1965 screws (packaged into 393 boxes) - [5 screws per box]
Why Was This Recalled?
Lack of pouch seal. Product is labelled as sterile.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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