Aequalis Ascend Flex Shoulder System Reversed Platform — Class II medical device recall Z-2025-2021
Terminated recall by Tornier, Inc, reported 2021-07-21, distributed in IL, TX. Two lots have been swapped thus have the incorrect product in the package. The component may be of a different
| Recall number | Z-2025-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2021-05-28 |
| Classified | 2021-07-12 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2023-04-14 |
| Distributed | IL, TX |
| Countries outside the US | BE, FR, GB |
| Quantity | 20 |
| Lot numbers | 1179AW, 1197AW |
| Model numbers | DWF500, DWF510 |
| Expiration dates | 2026-02-24, 2026-02-25 |
Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reason for recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2025-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.