Recall Z-2989-2020 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Wright Medical Technology Inc
EVOLVE STEM 8.5MM Model # 496S085
| Date | Aug 26, 2020 |
| Status | Terminated |
| Reason | Lack of sterility assurance |
| Root cause | Process control |
| Action | Wright initiated a recall on 08/26/2020. It states the following: 1. Immediately cease all use and distribution of this affected lot 2. Immediately quarantine all recalled products you have found, and return all affected product to Wright Medical as soon as possible. 3. Contact Customer Service at 800-238-7117 for return instructions and replacement inventory. 4. If you have further distributed the affected product, please notify the applicable parties . You may copy and distribute this letter and Wright Medical will work directly with them to collect the recalled items. 5. Wright asks you t |
| Quantity | 16 stems |
| Distribution | USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain |
| FDA record | Open on fda.gov |