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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 9,215
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.
Part of a larger recall action
This product is one of 17 recalled by TEI Biosciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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