Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1033-2019 — 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 s

U.S. FDA — Device Enforcement · United States · 2019-02-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1033-2019
Date of alert: 2019-02-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ACell, Inc
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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