Date Initiated by Firm | July 19, 2013 |
Date Posted | August 09, 2013 |
Recall Status1 |
Terminated 3 on March 18, 2016 |
Recall Number | Z-1939-2013 |
Recall Event ID |
65698 |
510(K)Number | K100076 |
Product Classification |
Mesh, surgical, polymeric - Product Code FTL
|
Product | C-QUR TacShield Mesh (All sizes and shapes).
Intended for use in soft tissue deficiencies. |
Code Information |
Product lines with lot number 10405513 and higher |
Recalling Firm/ Manufacturer |
Atrium Medical Corporation 5 Wentworth Dr Hudson NH 03051-4929
|
For Additional Information Contact | same 603-880-1433 |
Manufacturer Reason for Recall | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions |
FDA Determined Cause 2 | Package design/selection |
Action | Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification.
Additional language to the instructions for use (IFU) to include:
Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable.
Questions please contact Atrium Medical Customer Service at 1- 800-
528-7486 Monday through Friday 9:00 am to 5:00 pm EDT. |
Quantity in Commerce | 15,630 units |
Distribution | USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela. |
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 = FTL
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