FDA-Device2017-02-15Class II
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.
Encore Medical, Lp
Hazard
The Empowr PS Insert was reported as missing the impaction slot feature.
Sold states
Nationwide Distribution to CO, NY, and FL
Affected count
24 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2017Don't want to check this manually?
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