Encore Medical recalls EMPOWR Acetabular System (REF 942-01-40H) due to swapped hip/knee parts in packaging. Surgeons may use incorrect components during surgery. Affected units have specific UDI-DI and lot numbers.
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Encore Medical is recalling its EMPOWR Acetabular System (10° Hooded, HXe+, 40H) because parts were swapped in the packaging. This could lead to surgeons using the wrong components for hip surgery when knee parts were mistakenly included. The recall affects specific units with the listed reference number and expiration date.
The packaging contains hip and knee parts mixed up before sealing. This means surgeons might use knee components during hip surgery, which could cause incorrect joint alignment and complications.
Surgeons using the EMPOWR Acetabular System (REF 942-01-40H) for hip surgeries. Patients who received this specific model during the recall period are at risk of using incorrect parts.
Check for the reference number 942-01-40H on the product label. The units have a specific UDI-DI (00190446309833) and lot number (629Z1114) with an expiration date of March 30, 2028.
Look for the reference number 942-01-40H on the product label to confirm if it's affected.
The recall is because knee insert and acetabular system parts were swapped within the inner pack before sealing, which could lead to surgeons using incorrect components during hip surgery.
The official recall notice does not specify a remedy or action for affected units. Check the product label for the reference number 942-01-40H to confirm if it's affected.
The recall indicates a risk of using incorrect parts during surgery, but the official notice does not specify that this could cause serious injury or death.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0103-2024 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0103-2024 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.