Recall Z-0366-2025

Reason for recall

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

FDA-determined cause: Under Investigation by firm

Action taken

Stryker issued Urgent Medical Device Recall Letter on 10/04/24 via Fed'X to Risk Manager, Materials Manager, OR Director. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. On behalf of Stryker, we thank you sincerely for your help and support in completing this action and regret any inconvenience that may be caused. We would like to reassure you that Stryker is committed to ensuring that only conforming devices, meeting our high internal quality standards and your expectations, remain on the market. If you have any questions about this matter, contact Stryker Instruments recall team directly by calling (269) 290-0524 or email at Instruments.Recalls@stryker.com. A Medical Device Recall Expansion notification letter dated 9/2/25 was sent to customers. Additional Lots A total of 47 lot numbers across two catalog numbers are listed below. Distribution dates in scope range from 03/29/2023 05/17/2024. Actions Needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return a new copy of the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A re