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EVOLVE recallZ-0005-2023 · Wright Medical Technology, Inc. · initiated Aug 3, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Wright Medical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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]."

Recall details

Recall number
Z-0005-2023
Status
Open, Classified
Initiated by the company
Aug 3, 2022
Posted by the FDA
Oct 4, 2022
Recalling firm
Wright Medical Technology, Inc.
Quantity
16 units
Product code
KWI
FDA submissions
K060731, K991915
Distribution
US Nationwide distribution.

Product description

stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, 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.

Code information (models, lots, serial numbers)

UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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