INCIPIO recalls reusable surgical instruments with reported TIG weld fractures. Affected units have specific lot numbers and product reference codes.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
INCIPIO is recalling reusable surgical instruments called Offset Cup Impactors that have reported fractures in the TIG welds. This could lead to instrument failure during surgery.
The recalled instruments have reported fractures in the TIG welds. This could cause the instrument to fail during surgery, potentially leading to complications for the patient.
Surgical teams using these instruments for hip joint implants are most at risk. Patients receiving these instruments during surgery may be affected.
Check for the product reference number 50341105 and lot number 24A0087 on the instrument. These units were sold with specific UDI-DI codes.
Look for product reference number 50341:105 and lot number 24A0087 on the instrument.
The recalled lot has reported incidents of fracture in the TIG weld, which could cause failure during surgery.
The official recall notice does not specify a remedy or action for affected instruments.
Check for product reference number 50341105 and lot number 24A0087 on the instrument.
We’ve drafted a message you can send INCIPIO DEVICES to request your refund or repair — edit it as you like.
Subject: Recall Z-0549-2025 — INCIPIO DEVICES INCIPIO DEVICES Hello, I own a INCIPIO DEVICES that is covered by recall Z-0549-2025 from INCIPIO DEVICES. 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.
