Encore Medical recalls RSP Standard Humeral Socket Insert (40mm) due to potential size mismatch with patient labels, risking incorrect implantation 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 humeral socket insert for potential size mismatch with patient labels. This could lead to incorrect implantation, causing physical impairment, discomfort, or the need for revision surgery.
The insert may have a size etched incorrectly compared to the patient's label. If surgeons implant the wrong size, it could cause physical impairment, discomfort, or require revision surgery.
Surgeons and patients who received the recalled insert (Part No. 509-00-440, Lot Numbers 387P1042A and 387P1045A) are at risk of incorrect implantation during surgery.
Check for Part No. 509-00-440 with Lot Numbers 387P1042A or 387P1045A. The product is sold under the RSP Standard Humeral Socket Insert (40mm) with HXe-Plus model.
Verify the part number and lot numbers on the product label to confirm if it matches the recalled items (Part No. 509-00-440, Lot Numbers 387P1042A or 387P1045A).
The recalled insert is the RSP Standard Humeral Socket Insert, 40mm plus 4mm, HXe-Plus, Part No. 509-00-440.
Incorrect implantation could cause physical impairment, discomfort, disruption of treatment, or the need for revision surgery.
Check for Part No. 509-00-440 with Lot Numbers 387P1042A or 387P1045A on the product 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-3022-2020 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-3022-2020 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.
