ACell recalls Gentrix Surgical Matrix Thick (30x40cm, PSMT3040, Lot 013948) due to one sample failing tensile strength tests. This may affect surgical tissue reinforcement safety.
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
ACell is recalling Gentrix Surgical Matrix Thick surgical mesh for potential tensile strength failure. This could compromise tissue reinforcement during surgery if the mesh doesn't meet strength requirements.
The mesh may not hold properly during surgery if it doesn't meet tensile strength specifications. This could lead to tissue failure in procedures where reinforcement is needed, such as hernia repairs or colon surgery.
Surgical patients and healthcare providers using Gentrix Surgical Matrix Thick for tissue reinforcement in procedures like hernia repair or colon surgery. The risk is low as only one sample failed tensile strength tests.
Check for the product name 'Gentrix Surgical Matrix Thick', catalog number PSMT3040, and lot number 013948. This product is used in specific surgical procedures like hernia repair or colon surgery.
Verify the product name, catalog number, and lot number to confirm if your item is affected.
One sample from the lot failed tensile strength tests, which could affect surgical tissue reinforcement safety.
The recall indicates a potential tensile strength issue, but only one sample failed tests. The risk is low as the product is used in specific surgical procedures.
Check the product details to confirm if it's affected; the recall doesn't specify a remedy or action needed.
We’ve drafted a message you can send ACell to request your refund or repair — edit it as you like.
Subject: Recall Z-1032-2019 — ACell ACell Hello, I own a ACell that is covered by recall Z-1032-2019 from ACell. 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.
