Reported Nov 21, 2018 · Terminated
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
AROA Biosurgery, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AROA Biosurgery, LTD. · 69 Gracefield Road · Lower Hutt · N/A
Is this the product you have?
OviTex 2S Reinforced BioScaffold 18x22cmPart Number F10258-1822G
- Lot codes and dates
- ERT-6E01 ERT-6I01 ERT-6J07
- Amount recalled
- 881 total
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new AROA Biosurgery, Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.