FDA Devices recall · Reported April 22, 2015
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Lu
A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of vis…
Integra LifeSciences Corp. recalled Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only … - a moderate-severity action.
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only … was recalled by Integra LifeSciences Corp. in April 22, 2015. Reason: A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified …. Check the official notice for the remedy. Verify recall #Z-1452-2015 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. issued this moderate-severity FDA Devices recall-A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified ….
- Moderate
- severity level
- Class II
- classification
- April 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1452-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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.
Product description
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
Reason for recall
A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1452-2015 |
| Date reported | April 22, 2015 |
| Date initiated | March 13, 2015 |
| Recalling firm | Integra LifeSciences Corp. |
| Firm location | Plainsboro, NJ |
| Affected scope | 287 packages ( 179 US 108 OUS ) |
| Distribution | Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom. |
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-1452-2015) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026