The Recall Desk
HighFDA (Devices)·Z-2073-2023·Announced 2023-07-12

SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues

TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.

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 an FDA Class II recall for a surgical implant where endotoxin contamination represents a risk-of-harm scenario. No illnesses or injuries have been reported, and the hazard is based on testing methodology issues rather than confirmed contamination, limiting the score to High per the severity rubric.

Plain-English summary

SurgiMend MP is a collagen matrix product used in soft tissue reconstruction surgery. The manufacturer, TEI Biosciences, issued a recall after identifying problems with the endotoxin testing procedures used during manufacturing and quality testing of finished goods.

Due to these testing issues, endotoxin test results for affected units may not be reliable or may not have been verified to be within specification. Approximately 3,992 units were distributed nationwide in seven different sizes to hospitals and surgical facilities.

Patients who have received implants containing SurgiMend MP should consult with their healthcare provider about their individual situation. Healthcare providers can identify affected units using the provided device identification numbers and UDI codes.

The recalled product

Product
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical Implant / Soft Tissue Reconstruction
Hazard
  • endotoxin
  • infection-risk

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 (7)

  • Item No. (UDI-DI): 606-206-001 (10381780357339)
  • 606-206-002 (10381780357360)
  • 606-206-003 (10381780357346)
  • 606-206-004 (10381780357353)
  • 606-206-005 (10381780357377)
  • 606-206-006 (10381780357384)
  • and 606-206-007 (10381780357391).

Distribution

Distributed nationwide across the United States.

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