Date Initiated by Firm | October 07, 2011 |
Date Posted | February 08, 2012 |
Recall Status1 |
Terminated 3 on May 21, 2013 |
Recall Number | Z-0986-2012 |
Recall Event ID |
60938 |
510(K)Number | K062353 |
Product Classification |
Filler, bone void, calcium compound - Product Code MQV
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Product | Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process. |
Code Information |
2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp 105 Morgan Ln Plainsboro NJ 08536-3339
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For Additional Information Contact | Mr. Srinivas Balusu 609-936-2464 |
Manufacturer Reason for Recall | Integra OS Osteoconductive Putty is labeled with incorrect storage conditions. |
FDA Determined Cause 2 | Error in labeling |
Action | Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product. |
Quantity in Commerce | 45 units |
Distribution | Nationwide Distribution - Including the states of CA, OK, MD and VA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MQV
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