Medical device manufacturer, Nobel Biocare production AB, has issued a medical device safety alert concerning its 17° Multi-Unit Abutment CC NP 2.5mm [Article number: 36614; Lot number: 12070802; Manufacturing Date: 29 August, 2016; Expiry Date: 29 July, 2019].
The manufacturer's Quality Management System has detected that a few parts of the affected product carry a product label where parts of the mandatory information, e.g. lot number and expiry date, are missing. Except for this missing information all products within this lot are according to specification and safe to use.
According to the manufacturer, the root cause is most likely related to an intermittent error in the transmission of data from the labelling system to the label printers. Lacking information regarding expiry date, single use and sterility might lead to usage of products beyond the shelf life which might lead to infections that might affect the osseointegration of the connected implant. The missing lot number information might also cause issues regarding the traceability of the affected product to the patient on a clinician/patient level.
The parts with a correct label, i.e. the retention sample, is confirmed correct. No significant public health impact beyond the users is foreseen with this issue.
The affected user is advised to return the affected product to the manufacturer for replacement.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 March 2018