Encore Medical recalls reverse shoulder prosthesis screws that may be 3.5mm instead of 5mm, risking surgical delays and poor fixation. Affected units have specific UDI-DI and lot numbers.
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Encore Medical is recalling reverse shoulder prosthesis screws that might be the wrong size (3.5mm instead of 5mm). Using these incorrect screws could cause surgery to be delayed or not fix properly.
The prosthesis package should contain 5mm screws but may include 3.5mm screws instead. This mismatch can cause surgical delays or inadequate fixation during the procedure.
Patients who received the recalled prosthesis screws during surgery are affected. Surgeons and medical teams handling these implants are most at risk.
Check for the UDI-DI number 00888912024570 and lot number 835C2074 on the packaging. The expiration date is March 2029.
Look for the UDI-DI number 00888912024570 and lot number 835C2074 on the packaging.
Using 3.5mm screws instead of 5mm screws could cause surgical delays or inadequate fixation.
Check for the UDI-DI number 00888912024570 and lot number 835C2074 on the packaging.
No, the recall is for the screws used during surgery, not the prosthesis itself.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0098-2024 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0098-2024 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.