Reported Nov 9, 2016 · Terminated
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized…
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
- Lot codes and dates
202351L01202434L01203779L01202351L02202434L02202351L03202434L03203779L03202351L04202434L04202351L05202434L05202351L06202434L06203779L06202351L07202434L07203779L07202351L08202434L08203779L08202351L09202434L09202351L10202434L10203203L01
- Amount recalled
- 436 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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