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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm June 17, 2016
Create Date September 07, 2016
Recall Status1 Terminated 3 on November 07, 2017
Recall Number Z-2743-2016
Recall Event ID 74613
Product Classification Anchor, suture, bone fixation, metallic - Product Code NOV
Product Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment
The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures
Code Information Model #'s 19700 and 19700ND
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-840-3431
Manufacturer Reason
for Recall		 Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.
FDA Determined
Cause 2		 Packaging
Action Integra sent an Urgent Voluntary Medical Device Recall letter and recall acknowledgment and return form dated June 17, 2016 to their customers via traceable courier. Customers were asked to review their inventory and complete the attached form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 717-840-3431.
Quantity in Commerce 6,729 units
Distribution Nationwide distribution
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.
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