stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/06/2024 via email. The notice explained the issue, potential risk, and requested the consignee isolate/quarantine the affected product pending return of the device. If the affected product was further distributed, please notify the applicable parties at once about this recall. This notification letter may be copied and distributed. a. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. For questions or concerns, please contact [email protected].