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Recall Observatory FDA recall evidence

Device product

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

Z-0766-2017

September 19, 2016

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 75645
Status
Terminated
Classification
Class II
Quantity
162 units
Official record key
device-enforcement:Z-0766-2017

Official wording

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.

Code information: 202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.