Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Reported: December 14, 2016 Initiated: November 15, 2016 #Z-0711-2017
Product Description
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Reason for Recall
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 7 units
- Distribution
- US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.. Recalled by Encore Medical, Lp. Units affected: 7 units.
Why was this product recalled? ▼
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0711-2017.
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