CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report

Aequalis Fx2 implant parts and instrument trays recalled by Tornier

Tornier is recalling Aequalis Fx2 implant parts and instrument trays, distributed in California, Michigan, Texas. The recall was initiated on 19 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0924AR, 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.

Quantity recalled30

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0699-2017
FDA event ID: 75444
Recalling firm: Tornier, Bloomington, MN
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2016
FDA classified: 2 Dec 2016
Reported: 14 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Sep 2016	Recall initiated by company
2 Dec 2016	Classified by FDA	+74 days
14 Dec 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Distribution TX, CA, and MI

California Michigan Texas

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

US Distribution TX, CA, and MI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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