Class 2 Device Recall Wright Medical Technologies

• Date Initiated by Firm: June 14, 2022
• Create Date: July 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1366-2022
• Recall Event ID: 90399
• Product Classification: Manual instruments designed for use with non-fusion spinous process spacer devices - Product Code QLR
• Product: Wright EVOLVE TRIAD Plate Cutter, REF 49510120
• Code Information: Lot codes: 955401, 1168853, 1349302, 1956936, 2486857
• 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: The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
• FDA Determined Cause: Device Design
• Action: The firm sent an URGENT MEDICAL DEVICE RECALL notice on beginning 06/14/2022 by letter (FedEx). The letter discussed the issue and potential risk, an requested the following actions be taken: "1. Immediately check your internal inventory to locate the product listed on the attached business reply form and remove them from their point of 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. 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 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. 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 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."
• Quantity in Commerce: 231
• Distribution: Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
• 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.