ACell, Inc: Medical Device Recall in 2019 - (Recall #: Z-1033-2019)

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:

Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Product Classification:

Class II

Date Initiated: February 14, 2019

Date Posted: March 27, 2019

Recall Number: Z-1033-2019

Event ID: 82228

Reason for Recall:

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Status: Terminated

Product Quantity: 1

Code Information:

SN KJ000423

Distribution Pattern:

US nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated