Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rim Plate Recalled by I.T.S. GmbH Due to The titanium implant has the wrong article number...
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 I.T.S. GmbH directly.
Affected Products
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
Quantity: 65 devices
Why Was This Recalled?
The titanium implant has the wrong article number laser marked on it.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About I.T.S. GmbH
I.T.S. GmbH has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report