Uromedica recalls ProACT Implantation Instrument Set (Model 750041, Lot UM00650) due to potential U-channel sheath damage to implant devices during use. Affected units may cause device damage when passed through sheaths.
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Uromedica is recalling ProACT Implantation Instrument Sets (Model 750041, Lot UM00650) because U-channel sheaths might cause damage to the implant devices when passed through them. This could lead to improper implantation or device failure.
The U-channel sheaths in the instrument set may not be properly manufactured or inspected, increasing the chance of damage to the ProACT implant device when it passes through the sheaths. This could result in improper implantation or device failure.
Surgical teams using the ProACT Implantation Instrument Set for medical procedures are most at risk. Patients receiving the implant may be affected if the device is damaged during insertion.
Check for the model number 750041 and lot number UM00650 on the instrument set. The product is a reusable, steam sterilizable surgical instrument set used for implant procedures.
Look for model number 750041 and lot number UM00650 on the instrument set.
The recalled product is Model 750041 with lot number UM00650.
The U-channel sheaths may be more likely to cause damage to ProACT implant devices when passed through them during use.
The recall record does not specify a remedy.
We’ve drafted a message you can send Uromed: ProACT to request your refund or repair — edit it as you like.
Subject: Recall Z-1808-2020 — Uromed: ProACT Uromed: ProACT Hello, I own a Uromed: ProACT that is covered by recall Z-1808-2020 from Uromed: ProACT. 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.
