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PriMatrix® Ag 607-105-225Recalls & reported problems

Tei Biosciences Inc. · PriMatrix® Ag Meshed Antimicrobial Dermal Repair Scaffold · Class U

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K100261); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 23, 2023Open, Classified

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    Z-2082-2023 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100261. One submission often covers many models, so check the product and lot details in each record.

  • Z-2080-2023 · May 23, 2023 · Open, Classified
    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
  • Z-2081-2023 · May 23, 2023 · Open, Classified
    PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

Other Dressing, wound, drug devices

All Dressing, wound, drug devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.