Uromedica recalls specific implantation instrument sets (REF 750041) due to potential damage to ProACT devices during surgery. Affected units have lot numbers UM00794 or UM00817.
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Uromedica is recalling implantation instrument sets that could damage ProACT medical devices during surgery. This risk occurs if the devices are passed through the sheaths during implantation procedures.
The U-channel sheaths in the instrument set can cause damage to ProACT implant devices when passed through during surgery. This could lead to improper device function or complications during the procedure.
Medical professionals using the UROMEDICA Implantation Instrument Set (REF 750041) for ProACT device implantations are most at risk. Patients receiving these procedures may also be affected.
Check for lot numbers UM00794 or UM00817 on the UROMEDICA Implantation Instrument Set (REF 750041). The product is nonsterile and sold under UDI 00180668000106.
Identify the lot number on the instrument set to confirm if it's affected (UM00794 or UM00817).
The recall is for medical professionals using the instrument set during implantation procedures. Patients are not directly affected by this recall.
The official recall notice does not specify a remedy or action steps beyond checking product details. Contact Uromedica directly for further assistance.
Check for lot numbers UM00794 or UM00817 on the UROMEDICA Implantation Instrument Set (REF 750041).
We’ve drafted a message you can send Uromedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0458-2022 — Uromedica Uromedica Hello, I own a Uromedica that is covered by recall Z-0458-2022 from Uromedica. 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.
