Recall record at a glance
| Official record | Z-0425-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | AROA Biosurgery, LTD. |
| Report date | Nov 21, 2018 |
| Recall initiation date | Apr 6, 2018 |
| Quantity | 881 total |
| Location | Lower Hutt, New Zealand |
Official product description
OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
Why the product 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.
Distribution information
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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