Integra Limited: Medical Device Recall in 2019 - (Recall #: Z-1338-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 31, 2019

Date Posted: May 22, 2019

Recall Number: Z-1338-2019

Event ID: 82653

Reason for Recall:

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

Status: Terminated

Product Quantity: 274 units

Code Information:

Lot Code: 2991332

Distribution Pattern:

Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil

Voluntary or Mandated:

Voluntary: Firm initiated