ACell recalls Gentrix Surgical Matrix Thick (PSMT2030, Lot 013948) due to one sample failing tensile strength tests during lot release. 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 a specific surgical mesh product (Gentrix Surgical Matrix Thick) because one sample from the batch failed tensile strength tests. This could mean the mesh might not hold properly during surgery, risking tissue damage.
The mesh was tested for tensile strength to ensure it holds under stress during surgery. One sample from the batch failed this test, which could mean the mesh might not reinforce tissue properly if used in procedures requiring strength.
Surgical patients and healthcare providers using Gentrix Surgical Matrix Thick for procedures like hernia repair or colon surgery. The risk is low as only one sample failed the tensile test.
Check for the product name 'Gentrix Surgical Matrix Thick', catalog number PSMT2030, and lot number 013948. This product is used in specific surgical procedures like hernia repair.
Verify the catalog number PSMT2030 and lot number 013948 on the product label.
The recall states one sample failed tensile strength tests during lot release, but the product is still intended for use in surgery. The manufacturer has not issued a stop-use order.
Look for the catalog number PSMT2030 and lot number 013948 on the product label. This product is used in specific surgical procedures like hernia repair.
The recall does not specify a remedy, so you should check with your healthcare provider or the manufacturer for guidance.
We’ve drafted a message you can send ACell to request your refund or repair — edit it as you like.
Subject: Recall Z-1033-2019 — ACell ACell Hello, I own a ACell that is covered by recall Z-1033-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
