Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aequalis Fx2 implant parts and instrument trays. Insert component : Recalled by Tornier, Inc Due to Tornier is conducting a recall on Aequalis Fx2...

Date: September 19, 2016
Company: Tornier, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tornier, Inc directly.

Affected Products

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.

Quantity: 30

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: CA, MI, TX

Affected (3 states)Not affected

About Tornier, Inc

Tornier, Inc has 17 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report