Recall Z-0006-2023 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Wright Medical Technology, Inc.
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.
| Date | Oct 4, 2022 (initiated Aug 3, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 32 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |