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-DWK206BDWK224B-DWK226BDWK230B-DWK23BDWK244B-DWK246BDWK250B-DWK252BDWK264B-DWK266BDWK270B-DWK272B
- Stem ComponentPart
- Number
DWK111B-DWK115BDWK121B-DWK126BDWK131B-DWK135B
- Product UsageTotal or partial replacement of the Gleno-humeral articulation
- Lot codes and dates
0924AR0809AR1110AR1290AR0811AR0151AR2447AR6082AQ5935AQ6373AQ7153AQ7532AQ9966AQ0018AQ0385AR0386AR0384AR3014AR6892AQ8250AQ6893AQ6924AQ8249AQ6853AQ6925AQ6962AQ8795AQ8210AQYKAD241YKAD244
- 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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