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.
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 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.
- Affected units
- 5,664
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.
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
Same manufacturer · TEI Biosciences, Inc.
See all →- HighRevize Collagen Matrix Recalled for Potential Endotoxin Testing Issues
FDA (Devices) · 2023-07-12
- HighPriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues
FDA (Devices) · 2023-07-12
- HighSurgical collagen matrix recall due to endotoxin testing failures
FDA (Devices) · 2023-07-12
- HighSurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues
FDA (Devices) · 2023-07-12
- HighPriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues
FDA (Devices) · 2023-07-12
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighBiomet Recalls Shoulder Implant Components Due to Endotoxin Levels
FDA (Devices) · 2020-06-03
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17
- HighSurgical patties recalled due to higher-than-expected endotoxin levels
FDA (Devices) · 2024-11-06
- HighSurgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels
FDA (Devices) · 2024-11-06
- HighMedtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
FDA (Devices) · 2023-07-26
- HighSurgical Patties and Strips Recalled for Elevated Endotoxin Contamination
FDA (Devices) · 2024-11-06