Class 2 Device Recall stryker

• Date Initiated by Firm: March 03, 2025
• Date Posted: April 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1651-2025
• Recall Event ID: 96494
• 510(K)Number: K100562
• Product Classification: Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
• Product: stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
• Code Information: GTIN 00846832015054, Batch Number CC0421265
• Recalling Firm/ Manufacturer: Tornier, Inc; 10801 Nesbitt Ave S; Bloomington MN 55437-3109
• For Additional Information Contact: Meghan Wells; 901-201-9298
• Manufacturer Reason for Recall: A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 03/03/2025 via Trackwise (email). The notice explained the issue, potential risk, and requested the following: "1. Immediately check your internal inventory to locate the product 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. Return the enclosed business reply form by email to confirm receipt of this notification/document product segregation. a. Response is required, even if you may not have any physical inventory on site anymore. Completing this form will allow us to update our records and will also negate the need for us to send any 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. a. If possible, inform us 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. 6. Please inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with current regulations. For questions or concerns, please contact memphis.fieldaction@stryker.com."
• Quantity in Commerce: 5 units
• Distribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
• 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 = JDB