The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2072-2023·Announced 2023-07-12

SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues

TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Endotoxin is a high-risk bacterial component capable of causing serious harm in surgical applications. However, no illnesses or injuries have been reported, and the issue involves testing procedure defects rather than confirmed contamination, keeping the severity at High per the rubric standard for risk-of-harm without reported injury.

Plain-English summary

SurgiMend 2.0 is a collagen matrix device used in surgical reconstruction of soft tissues. TEI Biosciences, Inc. is recalling the product due to possible out-of-specification endotoxin test results stemming from issues identified with both in-process and finished goods endotoxin testing procedures.

The recall affects approximately 2,392 units in multiple sizes that have been distributed nationwide to medical facilities and surgical centers. Endotoxins are bacterial components that can trigger harmful inflammatory responses if present in medical devices used in surgical applications.

Facilities and healthcare providers in possession of affected units should contact TEI Biosciences, Inc. for device replacement and handling instructions. No illnesses or injuries related to this issue have been reported to the FDA.

The recalled product

Product
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-Oval,
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical Tissue Matrix
Hazard
Affected units
2,392

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Item No. (UDI-DI): 606-200-002 (10381780112976)
  • 606-200-004 (10381780112983)
  • 606-200-006 (10381780112990)
  • 606-200-008 (10381780113003)
  • 606-200-009 (10381780113010)
  • 606-200-016 (10381780113027)
  • 606-200-017 (10381780113034)
  • 606-200-019 (10381780113041)
  • 606-200-020 (10381780113058)
  • and 606-204-100 (10381780113065).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by TEI Biosciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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