Recall Z-1101-2020 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Wright Medical Technology, Inc.
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
| Date | Dec 27, 2019 |
| Status | Terminated |
| Reason | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. |
| Root cause | Process control |
| Action | The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items. |
| Quantity | 39 devices |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060731 | EVOLVE MODULAR RADIAL HEAD Wrightmedicaltechnologyinc, Apr 19, 2006 |