DJO Surgical recalls Delta Ceramic Femoral Head implants (44mm + 4.0mm) due to potential infection from improper sterilization. Affected units have specific UDI-DI/Lot/Expiration codes. Contact for return or repair.
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 certain Delta Ceramic Femoral Head implants because they may not have been properly sterilized before shipping. If implanted, this could lead to infections requiring treatment, monitoring, and possible revision surgery.
The implants were not fully sterilized before shipment, which could lead to infections if implanted. Infections might require antibiotics, additional monitoring, and in some cases, revision surgery to remove the implant.
Orthopedic patients who received the recalled Delta Ceramic Femoral Head implants (44mm + 4.0mm) with UDI-DI/Lot/Expiration codes 00888912076210/878B1171/May 2, 2027. Patients who have had the implant installed are most at risk.
Check for the UDI-DI/Lot/Expiration codes: 00888912076210/878B1171/May 2, 2027 on the implant packaging or label. The product is a Delta Ceramic Femoral Head with a 44 mm size and 4.0 mm thickness.
Look for the UDI-DI/Lot/Expiration codes 00888912076210/878B1171/May 2, 2027 on the implant packaging or label.
The implants were not subjected to final sterilization before shipment, which could lead to infections if implanted.
Check the UDI-DI/Lot/Expiration codes on the implant packaging or label. If you have the codes 00888912076210/878B1171/May 2, 2027, contact DJO Surgical for instructions.
The recall states that improper sterilization could lead to infections requiring treatment, monitoring, and possible revision 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-2604-2023 — DJO Surgical DJO Surgical Hello, I own a DJO Surgical that is covered by recall Z-2604-2023 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.
