SurgiMend collagen matrices recalled for endotoxin test result quality issues
TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or confirmed contamination. The issue stems from testing procedure failure in endotoxin quality assurance, making this a voluntary precautionary recall.
Plain-English summary
TEI Biosciences, Inc. is recalling SurgiMend 1.0, a collagen matrix for soft tissue reconstruction. The recalled products are available in sizes 18x12 cm Thin and 10x15 cm Thin, with 52 units distributed nationwide in the United States. The product codes are UDI-DI 606-005-003 (10381780112952) and 606-005-004 (10381780112969).
The recall was issued due to possible out-of-specification endotoxin test results caused by issues with in-process and finished goods endotoxin testing procedures. This means test results for endotoxin contamination may not accurately represent the actual endotoxin levels in the devices.
Healthcare facilities and providers using SurgiMend 1.0 for soft tissue reconstruction are affected by this recall.
The recalled product
- Product
- SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 52
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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