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U.S. Department of Health and Human Services

Class 2 Device Recall Retractor f/Sciatic Nerve

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  Class 2 Device Recall Retractor f/Sciatic Nerve see related information
Date Initiated by Firm April 02, 2018
Create Date May 09, 2018
Recall Status1 Terminated 3 on October 16, 2019
Recall Number Z-1758-2018
Recall Event ID 79850
Product Classification Retractor - Product Code GAD
Product Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Code Information Lot numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall		 There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.
Quantity in Commerce 235
Distribution US Nationwide and Canada
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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