Recall Z-1091-2019 ยท HWC Screw, Fixation, Bone
Integra Limited
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.
| Date | Mar 1, 2019 |
| Status | Terminated |
| 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 110F |
| Root cause | Process control |
| Action | Integra LifeSciences Corp. notified consignees (Hospitals and Distributors) by letter delivered by courier service, facsimile or email about the initial notification on March 1st, 2019.Letter explains problem, health risk and action to take: examine inventory to determine if you have any affected lots with discolored temperature dots, where the dots look similar as pictures labeled UNACCEPTABLE on previous page.. If you do have any product with discolored temperature dots, stop using the product immediately, remove them from service and place in quarantine until the product can be returned. Co |
| Quantity | 232 total |
| Distribution | US Nationwide distribution in the states of OH, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051611 | MBARESORB IMPLANT Kinetikos Medical, Inc., Sep 6, 2005 |