FDA Medical Device Recalls (openFDA)
AROA Biosurgery, LTD.: OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
- Recall number
- Z-0430-2019
- Recalling firm
- AROA Biosurgery, LTD.
- Product
- OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
- Status
- Terminated
- Initiated
- 2018-04-06
- Posted
- not on file
- Terminated
- 2019-04-15
- Reason
- 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.
- Root cause
- Other
- Action
- Beginning in April 2018, customers were visited by representatives and the affected units were replaced.
- Quantity
- 881 total
- Distribution
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Lot, serial or model codes
- ERT-6E16 ERT-6F01
- 510(k) numbers
- ["K153633"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 3007321028
- Firm city
- Lower Hutt
- Firm state
- not on file
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28