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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Surgical Kits and Trays

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  Class 2 Device Recall DeRoyal Surgical Kits and Trays see related information
Date Initiated by Firm June 16, 2012
Date Posted July 13, 2012
Recall Status1 Terminated 3 on November 09, 2012
Recall Number Z-2008-2012
Recall Event ID 62457
Product Classification General surgery tray (kit) - Product Code LRO
Product Custom surgical kits and trays:
GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04
GEO-MED TOTAL HIP PACK, REF 89-6664.03

surgical kits
Code Information GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694   GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740 
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		 Surgical kits and trays contain Stryker Hytrel Togas which were 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		 Nonconforming Material/Component
Action DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.
Quantity in Commerce 303 units
Distribution Nationwide Distribution including SD and NE.
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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