Encore Medical recalls RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus due to incorrect labeling on knee and humeral socket implants. Affected units have model 509-00-036 and lot 378P1382.
Knee and Humeral socket implants contain incorrect labeling.
Encore Medical is recalling RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus implants because they have incorrect labeling. This could lead to improper use or complications during surgery if the labels are not accurate.
Incorrect labeling on the implant could cause confusion during surgery, potentially leading to improper placement or complications. The labeling error might affect the compatibility or fit of the implant in the patient's shoulder.
Patients who received this specific humeral socket implant during surgery are likely affected. Surgeons and medical facilities that used this model are at higher risk.
Check for model number 509-00-036 and lot code 378P1382 on the implant. This product was sold with GTIN 00888912144544.
Verify the model number and lot code on the implant to confirm if it matches the recalled items.
The recall is due to incorrect labeling on the knee and humeral socket implants, which could lead to improper use during surgery.
Check the model number and lot code on the implant. If it matches 509-00-036 and lot 378P1382, contact Encore Medical for further instructions.
The official recall does not mention a specific fix or remedy for this labeling error.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1460-2026 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1460-2026 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.
