Medical device manufacturer, DePuy Synthes, has issued a medical device safety alert concerning Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue [Part number: 498.813(S). Lot numbers: 2780518, 2781527, 2780516, 2780511, 2780509, 2780507].
Due to an error in production, the affected lots cannot be securely attached to the 6 mm longitudinal rods. This may result in surgical delay as the affected device cannot be tightened appropriately during surgery and an alternative device is required.
Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 March 2015