Reported Dec 13, 2023 · Ongoing
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO…
Encore Medical, LP
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: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
- Lot codes and dates
- Model Number243-01-108
- UDI-DI Code00190446231295
- Lot Number277W1114
- Model Number353-03-108
- UDI-DI Code00190446231295
- Lot Number213W1051
- Amount recalled
- 37 devices
Where it was sold
- Nationwide
Why it was recalled
Due to incorrect product/device within packaging.
This product could cause temporary or reversible health problems — stop using it.
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