Z-0006-2023Class II

stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial...

Name: Z-0006-2023 stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial...
Creator: Wright Medical Technology, Inc.
Published: 2022-08-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-08-03 / Open, Classified / root cause: labeling and UDI

FDA source

Wright Medical Technology, Inc. began a recall of stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration... on 2022-08-03. FDA classified it as Class II and gives the reason as "The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0006-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-03
Posted: 2022-10-04
Recalling firm: Wright Medical Technology Inc
Product: stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker sent an URGENT: MEDICAL DEVICE RECALL on August 19, 2022 by Fedex and email. The letter explained the issue and the hazard and requested the following actions: "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. 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. For questions or concerns, please contact [email protected]."
Quantity in commerce: 32 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI: (01)008404201856775(11)210831(17)290829 Lot Number 1704255

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0006-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-10-04
Z-0006-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-10-04

Product code KWI

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)