Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product 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
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Quantity: Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)
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