Encore Medical recalls AltiVate Reverse Small Socket Insert (Part 509-03-044) due to mislabeling that may delay or stop surgery. Affected units sold with lot number 964W100:1000.
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Encore Medical is recalling a specific shoulder surgery implant part because it's mislabeled, which could delay or stop surgery. This affects patients who need shoulder replacements and may require revision surgery.
The product is mislabeled, meaning it might not be the correct implant for surgery. This could lead to delays, stopping, or needing revision surgery if used incorrectly.
Patients undergoing shoulder arthroplasty procedures are most affected. The recall targets specific units sold with lot number 964W1000.
Check for the part number 509-03-044 on the product. Affected units were sold with lot number 964W1000.
Look for the part number 509-03-044 and lot number 964W1000 on the product.
The product is mislabeled, which may cause delays or stop surgery, requiring revision procedures.
Check the product label for part number 509-03-044 and lot number 964W1000. If it matches, contact Encore Medical for guidance.
The recall states mislabeling may delay or stop surgery, but no specific injury risk is mentioned.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0117-2021 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0117-2021 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.