Product Safety Recalls

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Davol, Inc. Recall 92213

Description: Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)

Davol, Inc. Recall 92213 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2243-2023
Event ID92213
Event DescriptionVentralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Quantity169 units
Recall ReasonBalloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Device Classification20230802
Device Code InfoUDI-DI: (01)00801741201950(17)240528(10) Lot Number HUGT1609
Center Classification Date20230727
Recall Initiation Date20230425
Recalling FirmDavol, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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