Device 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.
Z-0699-2017
Product summary
- Firm
- Tornier, Inc
- Event
- Event 75444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30
- Official record key
device-enforcement:Z-0699-2017
Official wording
Reason: 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.
Code information: 0924AR, 0809AR, 1110AR, 1290AR, 0811AR, 0151AR, 2447AR, 6082AQ, 5935AQ, 6373AQ, 7153AQ, 7532AQ, 9966AQ, 0018AQ, 0385AR, 0386AR, 0384AR, 3014AR, 6892AQ, 8250AQ, 6893AQ, 6924AQ, 8249AQ, 6853AQ, 6925AQ, 6962AQ, 8795AQ, 8210AQ, YKAD241, YKAD244.
Distribution pattern: US Distribution TX, CA, and MI
Derived failure modes
-
Unknown
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.