Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Reported: February 15, 2017 Initiated: January 10, 2017 #Z-1139-2017
Product Description
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Reason for Recall
The Empowr PS Insert was reported as missing the impaction slot feature.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 24 units
- Distribution
- Nationwide Distribution to CO, NY, and FL
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.. Recalled by Encore Medical, Lp. Units affected: 24 units.
Why was this product recalled? ▼
The Empowr PS Insert was reported as missing the impaction slot feature.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1139-2017.
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