Medical device manufacturer, Synthes, has issued a field safety notice concerning Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy with part number 338.002.
According to Synthes, wrong material (Stainless Steel) is indicated on the product label. The product is made of Cobalt Chrome (L605).
The mislabelled product, if detected, may result in user dissatisfaction and use of an alternative product with no harm anticipated. There is an unlikely potential that a user may desire to use a stainless steel guide wire because the patient has a known sensitivity to cobalt chrome-alloy. Although highly unlikely, if this situation were to occur the patient could experience an adverse tissue reaction.
According to the local supplier, the affected devices were not distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 08 May 2013