The Recall Desk
HighFDA (Devices)·Z-2069-2023·Announced 2023-07-12

SurgiMend soft tissue collagen matrix recalled for endotoxin testing verification issues

TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.

What this means for you

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: This is a Class II recall of a medical device where endotoxin contamination poses a potential health risk to surgical patients. No illnesses or injuries have been reported, placing this within the criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

TEI Biosciences is recalling SurgiMend Collagen Matrix for Soft Tissue Reconstruction due to issues with in-process and finished goods endotoxin testing that may have resulted in out-of-specification test results. The affected devices are available in multiple sizes for surgical use.

Endotoxins are bacterial contaminants that can cause serious systemic reactions if present above specified limits in medical devices. The recall was initiated because testing procedures were unable to reliably verify that products met required endotoxin specifications before distribution.

Approximately 14,535 units have been distributed domestically throughout the United States. Healthcare providers and facilities that received affected batches should immediately cease use and contact TEI Biosciences for product return and replacement instructions.

The recalled product

Product
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Soft tissue reconstruction device
Hazard
  • endotoxin-contamination

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 (20)

  • Item No. (UDI-DI): 606-001-002 (10381780112617)
  • 606-001-004 (10381780112624)
  • 606-001-005 (10381780112631)
  • 606-001-006 (10381780112648)
  • 606-001-007 (10381780112655)
  • 606-001-008 (10381780112662)
  • 606-001-009 (10381780112679)
  • 606-001-010 (10381780112686)
  • 606-001-012 (10381780112693)
  • 606-001-013 (10381780112709)
  • 606-001-014 (10381780112716)
  • 606-001-015 (10381780112723)
  • 606-001-016 (10381780112730)
  • 606-001-017 (10381780112747)
  • 606-001-018 (10381780112754)
  • 606-002-002 (10381780112761)
  • 606-002-003 (10381780112778)
  • 606-002-005 (10381780112785)
  • 606-003-001 (10381780112792)
  • 606-003-002 (10381780112808)

Distribution

Distributed nationwide across the United States.

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