ZES Brno, a.s. (“the Company” or “we”) would like to inform its customers, distributors and users of its devices about the decision of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, of Poland (“the Office”), ref. no. UR.D.WM.DNB.33.2021, of May 17, 2021. The Office ordered that our Renaissance® line of devices be withdrawn from the market and the products already sold be recalled.
In the period from August 2013 to November 2017, the medical devices in question were distributed and sold on the basis of a certificate issued by the Engineering Test Institute (Strojírenský zkušební ústav s.p.), a Czech testing institute as well as a notified body. At that time, a version 1.1 user manual was attached to each medical device sold. Subsequently, the manufacturer requested certification from another Czech notified body – the Institute for Testing and Certification (Institut pro testování a certifikaci, a. s.). While a new CE certificate was issued in November 2018 that included a range of new indications, some of the indications previously approved by the previous notified body as well as some information that did not correspond with the then current version of the instructions for use (version 5.1) remained on the company’s Polish website as a result of human error. This was pointed out by the Office.
The Company appreciates the efforts of the Office in ensuring patient safety and in eliminating the potential danger in a patient using a medical device to treat an indication not approved by the current notified body due to the lack of clinical evidence and/or in a patient choosing not to take or to delay standard therapy.
That being said, the decision of the Office is not a statement suggesting that the medical device has failed or caused an injury or deterioration of health. The market withdrawal and product recall ordered by the Office are measures of a preventive nature that only extend to the territory of the Republic of Poland and whose aim is to inform distributors in the Polish market and Polish users.
If it is necessary to apply measures vis-à-vis an end client, please contact your distributor in the Polish market.
We apologise for any inconvenience caused and would like to assure everyone of our commitment to client safety and well-being.