Recall Z-1089-2019— Integra Limited
Class II · Terminated
Class II FDA medical device recall by Integra Limited, initiated 2019-03-01, terminated 2020-06-22. It names one FDA 510(k) clearance: K051611. Product: 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.. 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.
- Recalling firm
- Integra Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-01
- Terminated
- 2020-06-22
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.