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.
FDA Recall Z-0699-2017 · Posted None
Recalling FirmTornier, Inc
Recall StatusTerminated
Product CodeKWS
Date Initiated2016-09-19
Date Terminated2018-05-31
Product Quantity30
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.
Firm 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 [email protected]. For questions contact the same.
Root Cause
Component design/selection
Distribution Pattern
US Distribution TX, CA, and MI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.