The Recall Desk
HighFDA (Devices)·Z-2075-2023·Announced 2023-07-12

SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures

TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification 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: FDA Class II medical device with identified testing failures affecting an implantable product that poses risk of harm. No adverse events reported. Meets the criterion for Severity 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

TEI Biosciences, Inc. is recalling SurgiMend 4.0, a prescription-only collagen matrix used for soft tissue reconstruction. The recall affects 5,664 units distributed nationwide in the United States.

The company identified possible out-of-specification endotoxin test results caused by issues in the in-process and finished goods endotoxin testing procedures. Endotoxins are bacterial toxins that could potentially cause adverse reactions in an implantable device. No adverse events or injuries have been reported to date.

Healthcare providers with questions about the recall should contact TEI Biosciences. Patients who may have received this implant should speak with their healthcare provider.

The recalled product

Product
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.
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical Implant / Soft Tissue Reconstruction
Hazard
  • endotoxin
  • quality-control-failure
  • testing-failure

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 (9)

  • Item No. (UDI-DI): 606-400-002 (10381780113201)
  • 606-400-004 (10381780113218)
  • 606-400-006 (10381780113225)
  • 606-400-009 (10381780113232)
  • 606-400-016 (10381780113249)
  • 606-400-017 (10381780113256)
  • 606-400-018 (10381780113263)
  • 606-403-001 (10381780113270)
  • and 606-404-001 (10381780113287).

Distribution

Distributed nationwide across the United States.

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