Gentrix Surgical Matrix Thick — Class II medical device recall Z-1033-2019
Terminated recall by ACell, Inc, reported 2019-03-27, distributed nationwide. The devices were released from a lot for which one sample failed to meet the company' s tensile strength speci
| Recall number | Z-1033-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACell, Inc, Columbia, MD, United States |
| Recall initiated | 2019-02-14 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | potency |
| Lot numbers | 013948 |
| Model numbers | PSMT2030 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1033-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.