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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHO TOTAL JOINT TRACECART(R)

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  Class 2 Device Recall ORTHO TOTAL JOINT TRACECART(R) see related information
Date Initiated by Firm May 30, 2013
Date Posted July 11, 2013
Recall Status1 Terminated 3 on July 12, 2013
Recall Number Z-1692-2013
Recall Event ID 65554
Product Classification General surgery tray (kit) - Product Code LRO
Product GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE

Product Usage: general surgical
Code Information Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal sent an Urgent: Voluntary Product Recall letter dated May 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, remove any affected product from their inventory, open its package to prevent use, and dispose in a standard trash receptacle. Customers were asked to complete the enclosed notice of destruction form and return it to DeRoyal by faxing it to 865-362-3716 or emailing it to recalls@deroyal.com. For question call 865-362-1034 or contact your DeRoyal representative.
Quantity in Commerce 87 units
Distribution USA Nationwide Distribution in the state of PA
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.
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