Class 2 Device Recall INFINITY"

• Date Initiated by Firm: March 06, 2024
• Date Posted: April 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1477-2024
• Recall Event ID: 94194
• 510(K)Number: K123954
• Product Classification: Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
• Product: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
• Code Information: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 1023 Cherry Rd; Memphis TN 38117-5423
• For Additional Information Contact: Meghan Wells; 901-201-9298
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process change control
• Action: 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 memphis.fieldaction@stryker.com.
• Quantity in Commerce: 47 units
• Distribution: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HSN