CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
OviTex 1S Reinforced BioScaffold 4x8cm recalled by AROA Biosurgery
Aroa Biosurgery is recalling OviTex 1S Reinforced BioScaffold 4x8cm, distributed in 8 states. The recall was initiated on 6 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0421-2019
- FDA event ID
- 81166
- Recalling firm
- Aroa Biosurgery, Lower Hutt
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2018
- FDA classified
- 9 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 6 Apr 2018 | Recall initiated by company | |
| 9 Nov 2018 | Classified by FDA | +217 days |
| 21 Nov 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Where it was distributed
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
AlabamaCaliforniaFloridaIndianaMassachusettsMichiganNew HampshireNew York
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
ERT-6G10
Where was it sold?
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
20 other products · FDA event 81166More recalls from Aroa Biosurgery
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery | Aroa Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex Reinforced BioScaffold 10x12cm recalled by AROA Biosurgery | Aroa Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 16x20cm recalled by AROA Biosurgery | Aroa Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 10x20cm recalled by AROA Biosurgery | Aroa Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery | Aroa Biosurgery | Potency & Assay | 8 states |
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