Reported Dec 18, 2019 · Ongoing
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
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 Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
- Lot codes and dates
- All Lots
- Amount recalled
- 410 devices
Where it was sold
Why it was recalled
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
This product could cause temporary or reversible health problems — stop using it.
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