Strattice Reconstructive Tissue Matrix 0616002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M32806160020), received between Apr 19, 2022 and Mar 17, 2025 — classified as 5 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP #1 TO REPORT ON 27/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A RECURRENT INCARCERATED INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT #S10832-147, REF. # (B)(4) ON (B)(6) 2010. CAPTURING CATALOG NUMBER AS 1620002. ON (B)(6), PATIENT UNDERWENT A REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT #S10705-031, REF. #(B)(4). PATIENT ALSO UNDERWENT A REMOVAL OF PREVIOUS ABDOMINAL WALL MESH PROCEDURE AND LYSIS OF ADHESIONS. ON (B)(6) 2019, PATIENT UNDERWENT OPEN RIVES-STOPPA VENTRAL HERNIA REPAIR WITH TRANSVERSUS ABDOMINIS RELEASE (TAR), MESH EXCISION AND SKIN FLAP CREATION. THE FORM LISTS THE CONDITION THAT WAS TREATED: FROM 2009 THROUGH 2012, HERNIA SYMPTOMS, HERNIA SURGERIES, POST-OP FOLLOW-UPS. (B)(6) 2010 - DRAINAGE OF INTRA-ABDOMINAL, ABSCESS, LYSIS OF ADHESIONS, REMOVAL OF PREVIOUS ABDOMINAL WALL MESH, REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH (1ST STRATTICE IMPLANT). (B)(6) 2010 - DRAIN SITE INFECTION. (B)(6) 2010 - REPAIR OF RECURRENT INCARCERATED INCISI

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion; Post Operative Wound Infection

  MAUDE report 21620921 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 45 YEAR OLD FEMALE HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT # SP100326-060; REF # 0616002) MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 17034779 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER SP100262-317. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, FOR A MESH REVISION OPERATION.

  Patient problems: Hernia

  MAUDE report 16545319 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH PRODUCT; MODEL NUMBER: 0616002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017 AND UNDERWENT A MESH REVISION OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16473240 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2011. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHES. THE RECORDS INDICATE THESE WERE A STRATTICE FIRM 16 X 20 AND STRATTICE FIRM 6 X 16 MESH. AFTER SURGERY, THE PATIENT HAD SEVERAL REVISION SURGERIES INCLUDING: (B)(6) 2012, DURING WHICH A STRATTICE FIRM 10 X 16 MESH WAS IMPLANTED, (B)(6) 2014, REVISION SURGERY DURING WHICH A STRATTICE FIRM 16 X 20 MESH WAS IMPLANTED AND (B)(6) 2015, SURGERY DURING WHICH A STRATTICE FIRM 20 X 40 MESH WAS IMPLANTED. THIS RECORD IS ASSOCIATED WITH THE SECOND STRATTICE FIRM 6 X 16 MESH IMPLANTED ON (B)(6) 2011. RECORD 2 OF 5.

  Patient problems: Hernia

  MAUDE report 14147811 ↗