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U.S. Department of Health and Human Services

Class 2 Device Recall bioBLOCK Implant

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  Class 2 Device Recall bioBLOCK Implant see related information
Date Initiated by Firm March 01, 2019
Create Date April 05, 2019
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-1090-2019
Recall Event ID 82361
510(K)Number K051611  
Product Classification Screw, fixation, bone - Product Code HWC
Product 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.
Code Information Lot Numbers: FGD2096, FGD8328
Recalling Firm/
Manufacturer		 Integra Limited
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer 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
FDA Determined
Cause 2		 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. 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 custsvcnj@integralife.com .
Quantity in Commerce 232 total
Distribution US Nationwide distribution in the states of OH, MI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = KINETIKOS MEDICAL, INC.
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