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U.S. Department of Health and Human Services

Class 2 Device Recall Symmetry and CODMAN(R) brands, QUADLOCK (TM) Sterilization Container

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 Class 2 Recall
Symmetry and CODMAN(R) brands, QUADLOCK (TM) Sterilization Container
see related information
Date Posted January 27, 2014
Recall Status1 Open
Recall Number Z-0833-2014
Recall Event ID 67171
Premarket Notification
510(K) Number
K120117 
Product Classification Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
Product Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Medium Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive,
Code Information all lots
Recalling Firm/
Manufacturer
Symmetry Medical/SSI
3034 Owen Dr
Antioch, Tennessee 37013-2413
For Additional Information Contact Ajey Atre
800-251-3000
Manufacturer Reason
for Recall
The Quad-Lock(TM) Sterilization Container System may not maintain an effective sterile barrier.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical.
Quantity in Commerce 2,991 units
Distribution Nationwide and PR International: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Columbia, Korea, Chile
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = Codman & Shurtleff, Inc.
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