14 results
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75ms
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Sources: EU EUDAMED, US FDA
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
FDA Recall
Terminated
·Surgical Tissue Network, Inc.·Product code MQV·March 14, 2012
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
FDA Recall
Terminated
·Surgical Tissue Network, Inc.·Product code MQV·March 14, 2012
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
FDA Recall
Terminated
·Surgical Tissue Network, Inc.·Product code MQV·March 14, 2012
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
FDA Enforcement
Class II
·Terminated·Surgical Tissue Network, Inc.·January 16, 2013
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
FDA Enforcement
Class II
·Terminated·Surgical Tissue Network, Inc.·January 16, 2013
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
FDA Enforcement
Class II
·Terminated·Surgical Tissue Network, Inc.·January 16, 2013
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 9, 2022
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 7, 2022
DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·October 15, 2022
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 9, 2019
ENDOWRIST;DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·August 5, 2020
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 7, 2020
DAVINCI 5
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 11, 2025
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 20, 2019