Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Metalogix Self-Drill Half-Pin Recalled by New Standard Device Inc Due to Complaints were received for Self-drill Half-Pin tip breakages...
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 New Standard Device Inc directly.
Affected Products
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Quantity: 410 total devices
Why Was This Recalled?
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Where Was This Sold?
This product was distributed to 11 states: AZ, GA, IL, MT, NV, NJ, NC, OH, PA, TX, VA
About New Standard Device Inc
New Standard Device Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report