OviTex 2S Reinforced BioScaffold 18x22cm recall: Impurity Out of Spec
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Why was OviTex 2S Reinforced BioScaffold 18x22cm 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ERT-6E01 ERT-6I01 ERT-6J07
- Product
- OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
- Recalling firm
- AROA Biosurgery, LTD.
- Quantity
- 881 total
- Distribution
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)