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U.S. Department of Health and Human Services

Class 2 Device Recall SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP

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  Class 2 Device Recall SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP see related information
Date Initiated by Firm June 16, 2015
Date Posted July 30, 2015
Recall Status1 Terminated 3 on May 26, 2016
Recall Number Z-2316-2015
Recall Event ID 71300
Product Classification Clamp - Product Code HXD
Product SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only.

Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
Code Information 149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.
Recalling Firm/
Manufacturer		 Symmetry Surgical, Inc.
3034 Owen Dr
Antioch TN 37013-2413
For Additional Information Contact Customer Service
800-251-3000
Manufacturer Reason
for Recall		 Lack of sterility assurance.
FDA Determined
Cause 2		 Package design/selection
Action The firm initiated their recall by via US certified mail, with return receipt requested, beginning on 06/18/2015. The Urgent Medical Device Recall letter, dated June 16, 2015, identified the affected product, as well as the reason for the recall. The letter discussed the potential harm associated with the issue, and requested that the consignees examine their inventory and discontinue use immediately. Customers should promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted lots. Symmetry Surgical Customer Service should be contacted with questions or any other needs.
Quantity in Commerce 2,708 units
Distribution Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.
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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