Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 27, 2019
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,
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
ACell, Inc recalled Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product U… - a moderate-severity action.
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product U… was recalled by ACell, Inc in March 27, 2019. Reason: The devices were released from a lot for which one sample failed to meet the company' s tensile strength spec…. Check the official notice for the remedy. Verify recall #Z-1032-2019 with the FDA Devices before acting.
The recall
ACell, Inc issued this moderate-severity FDA Devices recall-The devices were released from a lot for which one sample failed to meet the company' s tensile strength spec….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- March 27, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1032-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1032-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on February 14, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. ACell, Inc is listed as the recalling firm, operating out of Columbia, MD. Federal records list the affected scope as 1.
The documented reason for this recall is: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. Distribution data in the federal record shows the product reached: US nationwide distribution in the state of CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1
Related Recalls
6
6 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1032-2019 |
| Date reported | March 27, 2019 |
| Date initiated | February 14, 2019 |
| Recalling firm | ACell, Inc |
| Firm location | Columbia, MD |
| Affected scope | 1 |
| Distribution | US nationwide distribution in the state of CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1032-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ACell, Inc. Units affected: 1.
Why was this product recalled? ▼
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2019. Severity: Moderate. Recall number: Z-1032-2019.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution in the state of CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1032-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.