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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal KNEE ARTHROSCOPY PACK

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 Class 2 Device Recall DeRoyal KNEE ARTHROSCOPY PACKsee related information
Date Initiated by FirmJune 04, 2014
Date PostedJuly 29, 2014
Recall Status1 Terminated 3 on May 05, 2015
Recall NumberZ-2124-2014
Recall Event ID 68744
Product Classification General surgery tray (kit) - Product Code LRO
ProductDeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
Code Information Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactTracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
FDA Determined
Cause 2		Packaging change control
ActionThe recall was initiated by letter delivered via UPS on 6/4/2014. The firm requested that the consignee contact Stericycle to arrange for return and replacement of the product. A second notice was sent on 7/22/2014 to those accounts who did not respond to the initial notice. Distributors were requested to notify their end-users or provide a list of end-users to DeRoyal for direct notification. Effectiveness checks will be sent via email for those customers who have provided an email contact and via UPS for those customers who have not responded.
Quantity in Commerce128 units
DistributionDistributed in the states of MI, GA, OH, IL, MO, and IN.
Total Product Life CycleTPLC 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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