FDA Device recall Z-2989-2020
EVOLVE STEM 8.5MM Model # 496S085
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of EVOLVE STEM 8.5MM Model # 496S085 by Wright Medical Technology, citing lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2989-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-26 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Wright Medical Technology |
| Distribution | CA, CO, FL, GA, MA, MO, OH, PA, TX |
Product
EVOLVE STEM 8.5MM Model # 496S085
Reason
Lack of sterility assurance
Identifiers
| code_info | Lot # 1668777 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2989-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.