Z-0699-2017 Class II Terminated
FDA device recall Z-0699-2017 was initiated by Tornier, Inc on Sep 19, 2016 and is designated Class II. 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. The recall status is terminated (terminated May 31, 2018). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2016
- Initiation Date
- Sep 19, 2016
- Termination Date
- May 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
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.
Distribution Pattern
US Distribution TX, CA, and MI
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0699-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026