Encore Medical recalls Reverse Shoulder System e+ (REF 509-01-032) due to mislabeling. Affected units have specific UDI and lot numbers. No action needed per recall details.
Mislabeling
Encore Medical is recalling a specific Reverse Shoulder System e+ implant due to mislabeling. This means the product may not be correctly identified, which could lead to improper use or complications during surgery. Affected units have a unique device identifier and specific lot numbers.
Mislabeling can cause the implant to be incorrectly identified, potentially leading to improper surgical procedures or complications. This risk is specific to the product's intended use in medical procedures.
Patients who received the Reverse Shoulder System e+ implant with the specified UDI and lot numbers are affected. Surgeons and medical staff using this product are at risk if they use mislabeled units.
Check for the unique device identifier (UDI) (01)00888912144612 and lot number 381P1167 on the product packaging. The product is labeled as Reverse Shoulder System e+ (REF 509-01-032), RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797.
Verify the unique device identifier (UDI) (01)00888912144612 and lot number 381P1167 on the product packaging.
The recall is for mislabeling, which could lead to improper use during surgery. However, the hazard is not described as causing serious injury in normal use, so the risk is low.
No action is required per the recall details. The product is safe to use if it has the correct UDI and lot number.
Check the product for the UDI (01)00888912144612 and lot number 381P1167. If it matches, no action is needed. If not, contact Encore Medical for further guidance.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0625-2024 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0625-2024 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.
