DJO Surgical recalls Altivate Reverse Humeral Stem (Size 6 x 108mm) due to potential infection from improper sterilization. Affected units have UDI-DI/Lot: 00190446259091/923W1411 from April 2029. Contact for replacement.
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
DJO Surgical is recalling Altivate Reverse Humeral Stem implants (Size 6 x 108mm) because they may not have been properly sterilized before shipping. If implanted, this could cause infections requiring treatment, monitoring, and possible surgery.
The implant components were not fully sterilized before shipment. If implanted, this could lead to infections that might need antibiotics, extra monitoring, or even surgery to fix the problem.
Patients who received this specific orthopedic implant during surgery in April 2029 or later are affected. Those with the UDI-DI/Lot number 00190446259091/923W1411 are most at risk.
Check for the UDI-DI/Lot number 00190446259091/923W1411 on the implant packaging. This product was sold starting in April 2029.
Look for the UDI-DI/Lot number 00190446259091/923W1411 on the implant packaging or documentation.
The implant components were not properly sterilized before shipment, which could lead to infections if implanted.
Check the UDI-DI/Lot number on your implant packaging. If it matches 00190446259091/923W1411, contact DJO Surgical for further instructions.
The recall states a risk of infection, which may require treatment, monitoring, or surgery, but does not mention immediate serious injury risks.
We’ve drafted a message you can send DJO Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2607-2023 — DJO Surgical DJO Surgical Hello, I own a DJO Surgical that is covered by recall Z-2607-2023 from DJO Surgical. 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.