Z-1033-2019Class II

Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 -

Name: Z-1033-2019 Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 -
Creator: ACell, Inc
Published: 2019-02-14
License: https://open.fda.gov/license/

ACell, Inc / initiated 2019-02-14 / Terminated / root cause: manufacturing process

FDA source

ACell, Inc began a recall of Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to... on 2019-02-14. FDA classified it as Class II and gives the reason as "The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1033-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-14
Posted: 2019-03-21
Terminated: 2020-05-07
Recalling firm: ACell, Inc
Product: 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 code: FTM Mesh, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.
Quantity in commerce: 1
Distribution: US nationwide distribution in the state of CA.
Product codes and lots: SN KJ000423

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1032-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-21
Z-1033-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-21

Product code FTM

K170763Class IIGentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. / cleared 2017-06-08

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)