Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Reported: December 21, 2016 Initiated: September 19, 2016 #Z-0766-2017
Product Description
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Reason for Recall
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 162 units
- Distribution
- Nationwide Distribution
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant. Recalled by Encore Medical, Lp. Units affected: 162 units.
Why was this product recalled? ▼
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0766-2017.
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