Encore Medical recalls EMPOWR Locking Femoral Impactor parts due to breakage risks and potential misalignment causing surgery delays or complications.
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
Encore Medical is recalling EMPOWR Locking Femoral Impactor parts (Part # 800-05-035) because they can break or become misaligned during surgery. This may cause delays, infections, or pain if not properly seated.
The tips of the impactor can break, leading to misalignment with the implant. This may cause off-axis loading, increasing the risk of device failure, surgery delays, infections, or pain.
Orthopedic surgeons and medical staff who use these implants during hip surgeries are most at risk. Patients receiving this specific implant may experience complications if the device fails during surgery.
Check for the part number 800-05-035 in the instrument tray FA EMP PAT TOOL KIT (part # 800-99-096). All lots of this product are affected.
Inspect the impactor for any signs of breakage or misalignment before use.
Reach out to Encore Medical for guidance on proper use or potential fixes.
Yes, the tips of the impactor can break, which may cause misalignment and increase the risk of device failure.
If not seated properly, it can cause off-axis loading, leading to surgery delays, infections, or pain.
The recall does not specify a fix; users should contact Encore Medical for guidance.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0611-2020 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0611-2020 from Encore Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
