The Recall Desk
HighFDA (Devices)·Z-2074-2023·Announced 2023-07-12

SurgiMend 3.0 Soft Tissue Graft Recalled for Endotoxin Testing Defect

SurgiMend 3.0 collagen matrix is being recalled nationwide (13,390 units) due to possible endotoxin contamination from deficiencies in endotoxin testing procedures.

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: Class II FDA recall for an implantable collagen matrix device with potential endotoxin contamination from testing procedure deficiencies. Endotoxin in medical implants presents a high-risk contamination hazard. Per FDA guidelines, Class II recalls without reported hospitalizations qualify as High severity rather than Severe.

Plain-English summary

SurgiMend 3.0 is a collagen matrix medical device for soft tissue reconstruction, manufactured by TEI Biosciences, Inc. The prescription-only product is available in multiple sizes from 1x5 cm to 25x40 cm, including fenestrated variants. The nationwide recall affects 13,390 units.

The recall was issued due to possible out-of-specification endotoxin test results stemming from identified issues with in-process and finished goods endotoxin testing. These testing deficiencies raise concerns that some devices may not have been properly verified for endotoxin levels.

The FDA has classified this as a Class II recall.

The recalled product

Product
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 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical Implant
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 (12)

  • Item No. (UDI-DI): 606-300-002 (10381780113072)
  • 606-300-004 (10381780113089) 606-300-006 (10381780113096)
  • 606-300-008 (10381780113102)
  • 606-300-009 (10381780113119)
  • 606-300-016 (10381780113126)
  • 606-300-017 (10381780113133)
  • 606-300-019 (10381780113140)
  • 606-300-020 (10381780113157)
  • 606-300-021 (10381780113164)
  • 606-300-022 (10381780113171)
  • 606-304-001 (10381780113188)
  • and 606-304-002 (10381780113195).

Distribution

Distributed nationwide across the United States.

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