Medical device manufacturer, Tornier, has issued a field safety notice concerning radial head prosthesis – MoPyC – Head with the following details:

• Model: small
• Catalogue number: PTR-H18
• Serial numbers.: 0743AMxxx - 5886AMxxx - CB2-425/xx - CB2-243/xx - CB2-244/xx - CB2-245/xx - CB2-146/xx

According to the manufacturer, complaints were recorded concerning some cases of broken MoPyC heads. The manufacturer has identified that some lots, manufactured in limit of tolerances, had a slightly more frequent risk of rupture.

The manufacturer advises users to quarantine and return the affected products.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 22 Jan 2014