TEI Biosciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
16
Inspections
6
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-2073-2023Class IISurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13xMay 23, 2023
Z-2080-2023Class IIPriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8May 23, 2023
Z-2076-2023Class IISurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cmMay 23, 2023
Z-2082-2023Class IIPriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cmMay 23, 2023
Z-2070-2023Class IISurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7xMay 23, 2023
Z-2081-2023Class IIPriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm,May 23, 2023
Z-2083-2023Class IIRevize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.May 23, 2023
Z-2074-2023Class IISurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15May 23, 2023
Z-2078-2023Class IIPriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mMay 23, 2023
Z-2077-2023Class IIPriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm,May 23, 2023
Z-2084-2023Class IIRevize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.May 23, 2023
Z-2085-2023Class IITissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.May 23, 2023
Z-2069-2023Class IISurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1May 23, 2023
Z-2071-2023Class IISurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x1May 23, 2023
Z-2072-2023Class IISurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15May 23, 2023
Z-2075-2023Class IISurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15May 23, 2023
Z-2079-2023Class IIPriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1),May 23, 2023
Z-0383-2018Class IIPriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is suppJune 15, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionFebruary 16, 2017
K153690PriMatrix Dermal Repair ScaffoldFebruary 22, 2016
K131286PRIMATRIX DERMAL REPAIR SCAFFOLDAugust 5, 2013
K100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDDecember 10, 2010
K083898SURGIMENDFebruary 4, 2009
K083440PRIMATRIX DERMAL REPAIR SCAFFOLDDecember 12, 2008
K071807ORTHOMEND SOFT TISSUE MATRIXAugust 6, 2007
K061407PRIMATRIX DERMAL REPAIR SCAFFOLDJune 29, 2006
K060829COSMATRIXMay 17, 2006
K060984XENFORM SOFT TISSUE REPAIR MATRIXMay 17, 2006
K060989TISSUEMEND SOFT TISSUE REPAIR MATRIXMay 15, 2006
K051766ORTHOMENDAugust 11, 2005
K051190XENFORM SOFT TISSUE REPAIR MATRIXJune 10, 2005
K023778DRESSSKINSeptember 29, 2003
K031188ORTHOMENDJune 27, 2003
K020455TISSUEMEND SOFT TISSUE REPAIR MATRIXApril 3, 2002