Recall Z-0325-2017— Encore Medical, Lp
Class II · Terminated
Class II FDA medical device recall by Encore Medical, Lp, initiated 2016-09-19, terminated 2017-10-20. It names one FDA 510(k) clearance: K160342. Product: Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.. Reason: 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-19
- Terminated
- 2017-10-20
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Empowr PS Knee System Box Cut Guide; 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
Data sourced from openFDA. This site is unofficial and independent of the FDA.