Recall Z-1366-2022 ยท QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Wright Medical Technology, Inc.
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
| Date | Jun 14, 2022 |
| Status | Open, Classified |
| Reason | 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 | 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 phy |
| Quantity | 231 |
| Distribution | Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.