Aequalis Fx2 implant parts and instrument trays — Class II medical device recall Z-0699-2017
Terminated recall by Tornier, Inc, reported 2016-12-14, distributed in CA, MI, TX. Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of disloca
| Recall number | Z-0699-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2016-09-19 |
| Classified | 2016-12-02 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-05-31 |
| Distributed | CA, MI, TX |
| Quantity | 30 |
| Model numbers | DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B, DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B |
Product
Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.
Reason for recall
Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.
Machine access
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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.