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U.S. Department of Health and Human Services

Class 2 Device Recall Symmetry Surgical ULTRA(R) Steam container

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  Class 2 Device Recall Symmetry Surgical ULTRA(R) Steam container see related information
Date Initiated by Firm November 29, 2016
Date Posted January 11, 2017
Recall Status1 Terminated 3 on August 20, 2017
Recall Number Z-1010-2017
Recall Event ID 75850
510(K)Number K113776  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136

Product Usage:
sterilization container
Code Information All
Recalling Firm/
Manufacturer		 Symmetry Surgical, Inc.
3034 Owen Dr
Antioch TN 37013-2413
For Additional Information Contact Allison Pullen
615-251-3000
Manufacturer Reason
for Recall		 Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).
Quantity in Commerce 7613 units
Distribution Worldwide 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.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = SYMMETRY MEDICAL
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