—#194316

Product

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

FDA product code: QLR — Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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."

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

Timeline

Recall initiated: 2022-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.