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PuraPly Micronized Wound Matrix (PuraPly MZ)
ORGANOGENESIS INC. · Model 515-061 · UDI-DI 00618474000404
KGN
Prescription
1
510(k) clearances
185
Adverse events (1 deaths)
23
Recalls
136
Facilities
Description
PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-02-10 | Medline Industries, LP | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.