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.
Reported: July 12, 2023 Initiated: May 23, 2023 #Z-2075-2023
Product Description
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.
Reason for Recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Details
- Recalling Firm
- TEI Biosciences, Inc.
- Units Affected
- 5,664 units
- Distribution
- Domestic: Nationwide Distribution.
- Location
- Boston, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by TEI Biosciences, Inc.. Units affected: 5,664 units.
Why was this product recalled? ▼
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2075-2023.
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