Encore Medical recalls Foundation Revision Knee prosthesis component (part 220-10-110) due to lack of FDA clearance. This unapproved device may pose risks for patients needing knee replacements.
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Encore Medical is recalling a specific knee prosthesis component (part number 220-10-1:110) because it hasn't been approved by the FDA. This means the device could be unsafe for patients who need knee replacements.
The device lacks FDA clearance, meaning it hasn't been tested or approved for safety and effectiveness. This could lead to complications during or after surgery, but the exact risk isn't specified in the recall notice.
Patients who have received this knee prosthesis component for a revision knee surgery are likely affected. Those with the specific part number 220-10-110 are at risk.
Check if you have the Foundation Revision Knee prosthesis component with part number 220-10-110. Look for lots numbers 866A1011 or 866A1022 on the packaging.
Identify the part number and lot numbers on the device to confirm if it's affected.
The recall states the device lacks FDA clearance, so it is not approved for safety and effectiveness. This means it may pose risks for patients needing knee replacements.
The recall does not specify a remedy, so you should contact Encore Medical directly to discuss next steps.
Look for part number 220-10-110 and lot numbers 866A1011 or 866A1022 on the device packaging.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2967-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-2967-2018 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.
