Recall Z-0699-2017— Tornier, Inc

Name: FDA recall Z-0699-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-19

Class II · Terminated

Class II FDA medical device recall by Tornier, Inc, initiated 2016-09-19, terminated 2018-05-31. It names 2 FDA 510(k) clearances: K152966, K141345. 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: 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..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Terminated: 2018-05-31
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K152966 — Aequalis Fx2Tornier S.A.S.·cleared 2016-01-14
K141345 — AEQUALIS FX2Tornier S.A.S.·cleared 2014-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.