DJO EMPOWR 3D Knee Tibial Insert Mispackaged—Risk of Wrong Implant
Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall of an orthopedic implant involving a packaging error that could result in implantation of a wrong-sized component. No injuries or illnesses have been reported. The hazard is a theoretical risk of joint debris without confirmed harm, placing this in the 'High' category per the rubric.
Plain-English summary
Encore Medical, LP is recalling DJO EMPOWR 3D Knee tibial inserts (Lot 078T1141). The 20 affected units were distributed nationwide to healthcare providers in Tennessee, Minnesota, Illinois, Indiana, South Carolina, Mississippi, California, and Kansas.
The recall stems from a packaging error: packages intended to contain a right-sided, size 8 knee tibial insert may instead contain a left-sided, size 4 knee tibial insert. If the incorrect implant is surgically placed, there is a risk of leaving debris in the joint space.
Patients who have received a knee implant from one of the affected distribution sites should contact their healthcare provider to confirm the correct implant was used. Healthcare providers should verify product contents and size before implantation.
The recalled product
- Product
- DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
- Manufacturer
- Encore Medical, LP
- Hazard
- mispackaging
- wrong-implant
- joint-debris
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 078T1141
Distribution
Distributed nationwide across the United States.
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