Z-0421-2019Class II
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
AROA Biosurgery Inc. / initiated 2018-04-06 / Terminated / root cause: manufacturing process
AROA Biosurgery, LTD. began a recall of OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0421-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- AROA Biosurgery Inc.
- Product
- OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
- Product code
- FTM Mesh, Surgical
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Other
- Action
- Beginning in April 2018, customers were visited by representatives and the affected units were replaced.
- Quantity in commerce
- 881 total
- Distribution
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Product codes and lots
- ERT-6G10
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0415-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0416-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0417-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0418-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0419-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0420-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0421-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0422-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0423-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0424-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0425-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0426-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0427-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0428-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0429-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0430-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0431-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0432-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0433-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0434-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0435-2019 | Class II | Terminated | Voluntary: Firm initiated |
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