Class 2 Device Recall Symmetry and CODMAN brands, QUADLOCK Sterilization Container

• Date Initiated by Firm: December 05, 2013
• Date Posted: January 27, 2014
• Recall Status: Terminated on April 13, 2015
• Recall Number: Z-0833-2014
• Recall Event ID: 67171
• 510(K)Number: K120117
• Product Classification: Sterilization wrap containers, trays, cassettes and other accessories - Product Code KCT
• Product: Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,
• Code Information: all lots
• FEI Number: 3007208013
• Recalling Firm/ Manufacturer: Symmetry Medical/SSI; 3034 Owen Dr; Antioch TN 37013-2413
• For Additional Information Contact: Ajey Atre ; 800-251-3000
• Manufacturer Reason for Recall: The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.
• FDA Determined Cause: Process control
• 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: Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Colombia, Korea, and Chile.
• 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