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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Procedural Trays

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  Class 2 Device Recall Custom Procedural Trays see related information
Date Initiated by Firm June 08, 2012
Date Posting Updated December 03, 2012
Recall Status1 Terminated 3 on December 10, 2012
Recall Number Z-0464-2013
Recall Event ID 62749
Product Classification General surgery tray (kit) - Product Code LRO
Product Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538

A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Code Information Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
Recalling Firm/
Merit Medical Systems, Inc.
12701 N Kingston Ave
Chester VA 23836-2700
For Additional Information Contact Joyce G. Braxton
Manufacturer Reason
for Recall
Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
FDA Determined
Cause 2
Process control
Action The firm, Merit Medical, sent an "URGENT PRODUCT RECALL NOTICE" letter dated June 8, 2012 to its customers by letter sent by US Postal Service - Certified Mail Receipt describing the problem, instructions as to actions that need to be taken, and requesting the customer to complete and sign the Customer Response Form and immediately fax a copy to this form to 1-804-416-1031. Customers were instructed to mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Should the customer choose to return the product for rework, they are to return the affected products by shipping them back to Merit Medical Systems via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department RGA #NC-53417, Merit Medical Systems, Inc., Attn: Manager of Quality Assurance and Regulatory Affairs, 12701 Kingston Ave., Chester, VA 23836. For questions customers were instructed to contact Manager of Quality Assurance and Regulatory Affairs at 1-804-416-1048 or email: jbraxton@merit.com.
Quantity in Commerce 83 packs
Distribution Nationwide distribution: US including states of: NE and SD.
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.