Reported Dec 14, 2016 · Terminated

Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B,…

Tornier, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109

Is this the product you have?

  • 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 ComponentPart
  • Number
    • DWK111B-DWK115B
    • DWK121B-DWK126B
    • DWK131B-DWK135B
  • Product UsageTotal or partial replacement of the Gleno-humeral articulation
Lot codes and dates
    • 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
Amount recalled
30

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 31, 2018 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.