Encore Medical recalls EMPOWR Acetabular System models 803-15-023 to 803-15-030 due to fracturing impactor balls that could cause joint debris. Affected patients should contact manufacturer for details.
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
Encore Medical is recalling specific models of EMPOWR Acetabular System implants because the impactor balls may fracture during use, potentially leaving debris in the joint. This could cause complications for patients who have received these implants.
The impactor balls in the EMPOWR Acetabular System can fracture during the impaction process. If this happens, debris may migrate or remain in the joint space, potentially causing complications for patients who have received the implant.
Patients who received the recalled EMPOWR Acetabular System implants (models 803-15-023 to 803-15-030) are most at risk. The recall applies to those who have undergone joint replacement surgery using these specific models.
Check if your EMPOWR Acetabular System implant has model numbers 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, or 803-15-030. The product is used in joint replacement surgeries for patients with conditions like osteoarthritis.
Reach out to Encore Medical directly for specific guidance on your implant model and next steps.
The recall does not require immediate discontinuation of use. Patients should contact Encore Medical for specific instructions.
Contact Encore Medical directly to discuss your specific implant model and receive guidance on next steps.
The recall indicates a risk of fracturing impactor balls that could cause debris in the joint space, but the remedy does not specify immediate action beyond contacting the manufacturer.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1929-2020 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1929-2020 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.