TEI Biosciences, Inc.
17 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for TEI Biosciences, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-12FDA-DeviceClass IITissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIRevize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIRevize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IIPriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend 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.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceClass IISurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
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