FDA (Devices) recall action 81166
The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material may degrade, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 4x8cm devices because the PGA suture material degraded, causing the devices to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 18x22cm devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them to fail burst specifications.