Z-1366-2022Class II

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Name: Z-1366-2022 Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Creator: Wright Medical Technology, Inc.
Published: 2022-06-14
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-06-14 / Open, Classified / root cause: design

FDA source

Wright Medical Technology, Inc. began a recall of Wright EVOLVE TRIAD Plate Cutter, REF 49510120 on 2022-06-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1366-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-14
Posted: 2022-07-12
Recalling firm: Wright Medical Technology Inc
Product: Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Product code: QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
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
Root cause tag: design
FDA 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 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
Product codes and lots: Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1366-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1366-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-11

Product code QLR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)