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.
FDA Recall Z-1090-2019 · Posted None
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Recalling FirmIntegra Limited
Recall StatusTerminated
Product CodeHWC
Date Initiated2019-03-01
Date Terminated2020-06-22
Product Quantity232 total
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 110F
Firm 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. Complete the attached Acknowledgement and Return Form. Questions Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or [email protected] .
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of OH, MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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