Home / Brands / TEI Biosciences
TEI Biosciences Recalls
18 recalls on record · January 24, 2018 to July 12, 2023 · Medical Devices
Recalls by year
18
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1)
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 c
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x1
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 1
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
July 12, 2023Medical DevicesFDA
TEI Biosciences, Inc. recalls SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x
Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
January 24, 2018Medical DevicesFDA
TEI Biosciences recalls PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a va
Hazard: During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.