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Recall Observatory FDA recall evidence

Device product

Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.

Z-0325-2017

September 19, 2016

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 75214
Status
Terminated
Classification
Class II
Quantity
436 units
Official record key
device-enforcement:Z-0325-2017

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. 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.

Code information: 202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01

Distribution pattern: US

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. 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.