Z-1338-2019Class II

Integra Flowable Wound Matrix Catalog No: FWD301

Name: Z-1338-2019 Integra Flowable Wound Matrix Catalog No: FWD301
Creator: Integra Limited
Published: 2019-03-31
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2019-03-31 / Terminated

FDA source

Integra Limited began a recall of Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined... on 2019-03-31. FDA classified it as Class II and gives the reason as "Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1338-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-31
Posted: 2019-05-15
Terminated: 2020-05-07
Recalling firm: Integra Lifesciences Sales LLC
Product: Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
FDA root cause: Under Investigation by firm
Action: Integra Lifesciences notified consignees (Hospitals, Distributors and Sales reps) by letter delivered by courier service, facsimile or email on April 1st, 2019. Letter identifies problems, health risk and action to take: review inventory, immediately stop use and return product and complete the Acknowledgment form. Questions Contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or [email protected].
Quantity in commerce: 274 units
Distribution: Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Product codes and lots: Lot Code: 2991332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1338-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1338-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15

Product code KGN

K072113UnclassifiedIntegra Flowable Wound Matrix, Model Fwd301Integra Lifesciences Corp. / cleared 2007-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)