Plainsboro, NJ, United States
Integra Limited recalls
2 recalls recorded since 2018, most recently on 31 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 March 2019
- Terminated
- 7 May 2020
- Reason
- Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
- Distribution
- Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1338-2019
- Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post
Terminated Class II Medical devices
- Recall started
- 1 March 2019
- Terminated
- 22 June 2020
- Reason
- Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
- Distribution
- US Nationwide distribution in the states of OH, MI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1089-2019, Z-1091-2019, Z-1090-2019
- Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
- Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
- Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.