The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Reason for recall: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand Quantity: 12 units Lot/code info: GTIN: 10603295049944; Lot: JN6613
10603295049944
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.