The Recall Desk
HighFDA (Devices)·Z-2076-2023·Announced 2023-07-12

Collagen surgical matrix recalled for potential endotoxin testing issues

TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin 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 device with risk of endotoxin contamination that could cause serious infection or inflammatory response, but no illnesses reported. Fits rubric criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a sterile collagen matrix used in soft tissue reconstruction surgery. The product (10cm x 20cm, Item No. 606-907-001) was distributed nationwide in the United States.

The recall was prompted by possible out-of-specification endotoxin test results. Problems identified in the in-process and finished goods endotoxin testing procedures mean that some distributed units may not have been properly tested for endotoxin content. Endotoxins are bacterial byproducts that can cause inflammatory responses.

This is an FDA Class II recall. Patients and healthcare providers with this product should be aware of this issue.

The recalled product

Product
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical reconstruction
Hazard
  • endotoxin

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 (1)

  • Item No. 606-907-001. No UDI-DI (Distributed in Canada and EU).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category