Class 2 Device Recall IMN Instrument System

• Date Initiated by Firm: March 28, 2025
• Date Posted: April 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1620-2025
• Recall Event ID: 96555
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S
• Code Information: Catalog number/REF: 2351-3080S; UDI-DI: 07613327361797; Lot #: KU155697, KU155698, KU155699, KU155700, KU155701, KU155702, KU155703, KU155704, KU155705, KU155706, KU155707, KU155708, KU155709, KU155710, KU155711, KU155712.
• FEI Number: 3002807830
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Meghan Wells; 1-901-201-9298
• Manufacturer Reason for Recall: The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
• FDA Determined Cause: Device Design
• Action: On March 28, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions needed by Customers and Distributors: Our records indicate that you may have received one or more of the subject devices. It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Immediately check your internal inventory to locate the product(s) listed on the attached Business Reply Form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Sign and return the enclosed Business Reply Form by email to to confirm receipt of this notification/documenting product segregation. a. Response is required, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also eliminate the need for us to send further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 3. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details. b. If you are a distributor, note that you are responsible for notifying your affected customers. 6. Please inform us of any adverse events and/or report them to the Health/C
• Quantity in Commerce: 1588 units
• Distribution: US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
• 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.