Dentists alerted to problems with Zimmer Biomet Hex Drivers
13 November 2017
Dentists are being alerted to an urgent medical device recall for the Zimmer Biomet 2.5 mm Hex Driver, with GemLock® Retention.
The Medicines and Healthcare Products Regulatory Agency (MHRA) have issued an alert relating to this and more advice and details of how to return the product can be found here.
Zimmer Biomet say the product may contain a manufacturing condition affecting the geometry of the driver’s hex feature, which prevents it from properly engaging with the implant mating component. Although there are no health consequences of using the device, it may cause delays during treatment and the company have recalled the product with immediate effect.
The affected Hex Driver units were sold between 1 February 2017 and 15 August 2017 and were distributed individually as well as part of an instrument kit. However, if the product was purchased as part of a kit it is not necessary to return the entire set as only the driver is being recalled.
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