Encore Medical recalls RSP Standard Humerus Socket Insert (44mm) due to possible size mismatch with patient labels, risking incorrect implant and surgery complications.
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
Encore Medical is recalling a specific humerus socket insert for potential size mismatch with patient labels. This could lead to surgeons implanting the wrong size, causing physical impairment, discomfort, or dislocation requiring revision surgery.
The insert may have a size marked differently than the patient label. If the surgeon implants the wrong size, it could cause physical impairment, discomfort, or dislocation requiring revision surgery.
Patients who received this specific humerus socket insert during surgery are at risk. Surgeons who used the recalled part may need to check the implant size against patient labels.
Check for the part number 509-00-044 on the insert. The lot number 380P1009A and UDI 00888912144568 are also associated with this recall.
Compare the size marked on the insert with the patient label to ensure they match.
The insert may be mislabeled with the size, risking the surgeon implanting the wrong size and causing physical impairment or dislocation.
Check the size on the insert against the patient label to ensure they match before any surgery.
The recall does not provide a specific fix; users must verify the size matches the patient label.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3021-2020 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-3021-2020 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.
