Recall Z-0699-2017 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tornier, Inc
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.
| Date | Sep 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | Wright sent an "Urgent Medical Device Recall" letter dated September 19, 2016. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and actions to be taken. It advised consignees to stop further distribution or use of product immediately. Requires consignees to notify all accounts that may be end-users, or contact Wright with your request for us to contact them. Advised consignee to complete and e-mail the attached questionnaire to FieldAction@wright.com. For questions contact the same. |
| Quantity | 30 |
| Distribution | US Distribution TX, CA, and MI |
| FDA record | Open on fda.gov |