SurgiMend® 606-005-002Recalls & reported problems

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.

3 other recalls cover devices cleared under the same FDA submission (K083898); 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-2070-2023 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083898. One submission often covers many models, so check the product and lot details in each record.

• Z-2072-2023 · May 23, 2023 · Open, Classified
  SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Ova
• Z-2075-2023 · May 23, 2023 · Open, Classified
  SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated
• Z-2074-2023 · May 23, 2023 · Open, Classified
  SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 c