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Terminated

Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, 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.

FDA Recall Z-1032-2019 · Posted None

Recalling FirmACell, Inc
Recall StatusTerminated
Product CodeFTM
Date Initiated2019-02-14
Date Terminated2020-05-07
Product Quantity1

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.

Firm Action

Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US nationwide distribution in the state of CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 2017-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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