Encore Medical recalls specific orthopedic shoulder implant components due to potential mix-up in packaging that could delay surgery. Affected items have unique identifiers; contact for details.
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Encore Medical is recalling a specific orthopedic shoulder implant component because two different devices were swapped during packaging. This could cause surgeons to use the wrong device during surgery, leading to delays.
The packaging mix-up means surgeons might receive the wrong device for surgery. This could cause delays in procedures if the incorrect device is used.
Orthopedic surgeons and hospitals that received the recalled implant component. Surgeons using the device during surgery are most at risk of delays.
Check for the product name 'RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus' with reference number 509-03-432. The unique identifier (UDI-DI) is 00190446257585 and lot number 954W1194.
Verify the product name, reference number, and unique identifiers to confirm if your item is affected.
Two different humeral socket insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, causing delays.
Check the product details to see if it matches the recalled item; contact Encore Medical for further instructions.
The recall is for potential delays in surgery, not a risk of serious injury. The hazard does not involve physical harm to users.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0281-2024 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0281-2024 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.