104 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
FDA Recall
Terminated
·TEI Biosciences·Product code KGN·June 15, 2017
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
FDA Recall
Open, Classified
·Product code KGN·February 10, 2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
FDA Recall
Terminated
·ProgenaCare·Product code KGN·April 18, 2022
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
PriMatrix; 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.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
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), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
FDA Recall
Terminated
·AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand·Product code KGN·November 27, 2018
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 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm
FDA Recall
Open, Classified
·Collagen Matrix Inc·Product code KGN·August 3, 2022
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code KGN·May 25, 2022
PriMatrix 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).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
FDA Recall
Terminated
·Integra Limited·Product code KGN·March 31, 2019
Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
FDA Recall
Terminated
·AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand·Product code KGN·November 27, 2018
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019