DePuy Orthopaedics recalls UNITE STD STEM SZ 8 implants with potential for surgical delay or bone damage if stems separate without proper fixation.
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
DePuy Orthopaedics is recalling UNITE STD STEM SZ 8 hip implants due to a risk that the stem might not securely attach to the bone without causing additional surgery or bone damage. This could lead to complications during hip replacement procedures.
The stems may have an undersized spigot bore diameter, which can cause the stem to separate from the proximal body during hip replacement surgery. This separation might require additional surgical intervention or cause bone damage if the stem cannot be properly fixed without surgery.
Patients who received the UNITE STD STEM SZ 8 hip implants with specific part numbers and lot numbers listed in the recall are most at risk. This affects individuals undergoing hip replacement surgery with these particular implants.
Check if your hip implant has the part number 110008100 and lot numbers listed in the recall (e.g., 9793035, 9802134, etc.). The product is sold globally under the UNITE STD STEM SZ 8 name.
Reach out to your surgeon to discuss whether your implant is affected by this recall and if any action is needed.
Check if your implant has part number 110008100 and one of the listed lot numbers to determine if it's affected.
Contact your surgeon to discuss potential next steps, as the recall requires evaluation for possible surgical delay or bone damage.
Look for part number 110008100 and lot numbers from the list provided in the recall notice.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-0484-2022 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-0484-2022 from DePuy. 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.
