| Class 2 Device Recall Retractor f/Sciatic Nerve |  |
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
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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
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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 |
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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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