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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile, ET0638 Head & Neck surgical kit

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  Class 2 Device Recall Sterile, ET0638 Head & Neck surgical kit see related information
Date Initiated by Firm April 22, 2015
Date Posted October 07, 2015
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-0057-2016
Recall Event ID 71904
Product Classification General and plastic surgery - Product Code FSY
Product regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Code Information Lot numbers 17580, 18551, and 19510. 
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803
For Additional Information Contact Robert W. Callahan
314-364-6561
Manufacturer Reason
for Recall		 The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
FDA Determined
Cause 2		 Process control
Action ROi initiated a recall of the custom kits via e-mail to their customers on April 22, 2015. The e-mail included their recall letter dated April 17, 2015. and the supplier's recall letter dated April 16, 2015. The customer was requested to discard the recalled component from their procedure tray at the time of set up and replace it with sterile stock. Customers were instructed to contact any ROi custom pack solutions manager with any concerns. The recalling firm issued a second e-mail notification on 10/19/2015 to the recall coordinator of the distributor. The notice informed them they had been receiving uncorrected product and reminded them to discard the defective component at the time the kit is set up for surgery. Any future distribution will be labeled with an alert to remove the defective component until the kits contain acceptable light handle covers. For questions regarding this recall call 314-364-6561.
Quantity in Commerce 114 kits
Distribution Distribution was made to LA, MS, and TX.
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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