Medical device manufacturer, Synthes GmbH, has issued a field safety notice concerning Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN) (Part number: 487.982; Lot number: prior to 6913910).
As the tab of some distractors may be oversized, there is the potential for the anterior footplates not to fit onto the Midface Distractor assembly (part number 487.982). Because recognition of the defined defect may not be detected until the intraoperative patient treatment period, there is the potential that the index surgical goals will not be achieved and a second unanticipated surgical intervention would be required. According to the manufacturer, there have been no adverse events associated with this issue.
The manufacturer advises users to quarantine and return all unused affected products.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 January 2014