Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Stryker Instruments, a Division of Stryker Corporation, Stryker Bipolar Forceps and Generator [Affected Products: Disposable Spetzler Malis Dual Irrigating Bipolar Forceps, Non-Stick; Disposable Spetzler Malis Slim Bipolar Forceps, Non-Stick; Stryker Bipolar Generator/Irrigator Interconnect Cable. Model or catalog number: 6780-200-005, 6780-230-010, 6780-230-005, 6760-180-015; Lot or serial number: 200731008, 200924012, 201022005, 200731007, 201008013, 201126013, 200806007, 200731010, 201001028, 201029011, 201015017, 201008016, 201015016, 201119005] [HKMD No.: 180293].
According to Health Canada, an error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life. It has been confirmed that the manufacturer's distribution system had the correct shelf life indicated therefore all distributed devices were shipped and delivered to customers with good shelf life remaining.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/stryker-bipolar-forceps-and-generator
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Sep 2023