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U.S. Department of Health and Human Services

Class 2 Device Recall Total Hip Tracecart

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  Class 2 Device Recall Total Hip Tracecart see related information
Date Initiated by Firm December 09, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on May 20, 2010
Recall Number Z-1072-2010
Recall Event ID 54113
Product Classification custom surgical kit - Product Code LRO
Product DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.
Code Information Lot numbers: 08150012, 08156012, 08179012, 08172012, 08221012, 08207012, 08247012, 08249012, 08302012, 08270012, 08310012, 08312012, 08354012, 09022012, and 08354012
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		 Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009
Quantity in Commerce 119 units
Distribution LA & MS
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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