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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Symmetry Surgical ULTRA(R) Sterrad containersee related information
Date Initiated by FirmNovember 29, 2016
Date PostedJanuary 11, 2017
Recall Status1 Terminated 3 on August 20, 2017
Recall NumberZ-1011-2017
Recall Event ID 75850
510(K)NumberK113776 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Productsymmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container
Code Information All
Recalling Firm/
Manufacturer		 Symmetry Surgical, Inc.
3034 Owen Dr
Antioch TN 37013-2413
For Additional Information ContactAllison 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
ActionSiemens 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 Commerce149 units
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KCT
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