Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF: 218-1604 Recalled by Osteomed, LLC Due to Screws for osteotomies have contain an undersize screwhead...
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 Osteomed, LLC directly.
Affected Products
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Quantity: N/A
Why Was This Recalled?
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Osteomed, LLC
Osteomed, LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report