ARTIA Reconstructive Tissue Matrix 16201097PRecalls & reported problems

Lifecell Corporation · ARTIA Reconstructive Tissue Matrix Perforated 16 cm X 20 cm · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M32816201097P0), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 injury.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Bacterial Infection1
Seroma1
Wound Dehiscence1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING FILED TO PRESENT UPDATED DEVICE SERIAL NUMBER, PATIENT HISTORY, TREATMENTS, AND CONCOMITANT MEDICATIONS.
Patient problems: Bacterial Infection; Seroma; Wound Dehiscence
MAUDE report 24205769 ↗

Device details

UDI-DI	`M32816201097P0`
Brand	ARTIA Reconstructive Tissue Matrix
Model	16201097P
Company	Lifecell Corporation
Product code	FTM · Mesh, Surgical
Class	Class 2
FDA submission	K162752
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 4, 2023

Device type (GMDN): Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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