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U.S. Department of Health and Human Services

Class 3 Device Recall LifeLiner

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 Class 3 Device Recall LifeLinersee related information
Date Initiated by FirmMay 08, 2013
Date PostedMay 16, 2013
Recall Status1 Terminated 3 on January 14, 2014
Recall NumberZ-1331-2013
Recall Event ID 65078
Product Classification Dress Surgical - Product Code FYE
ProductDePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
Code Information Lot - D12178C 
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactMindy Tinsley
574-372-7136
Manufacturer Reason
for Recall		LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.
FDA Determined
Cause 2		Labeling mix-ups
ActionDePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.,sent a " Urgent Information Medical Device Recall Notice" dated May 8, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please cease further distribution or use of the affected gloves immediately. Our records indicate your hospital purchased the affected lot. The purpose of this communication is to inform you of this recall and request acknowledgement of receipt of this letter by signing and returning the Hospital/User Facility Reconciliation Form within 10 business days of receiving this notice. Response cards should be faxed to (574) 371-4964. Please contact your DePuy Synthes Joint Reconstruction Sales Representative for assistance returning any unused affected gloves. For product related questions, please contact your local DePuy Synthes Joint Reconstruction Sales Consultant. For clinical questions from surgeons, please contact DePuy Synthes Joint Reconstructions Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.- 5 p.m. EDT). For questions about device recall information provided, please call (574)371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
Quantity in Commerce180 gloves (120 gloves distributed in the US)
DistributionWorldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.
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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