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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes VA Implant Rack for the Compact Distal Radius System

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  Class 2 Device Recall Synthes VA Implant Rack for the Compact Distal Radius System see related information
Date Initiated by Firm November 29, 2016
Date Posted December 21, 2016
Recall Status1 Terminated 3 on August 03, 2017
Recall Number Z-0867-2017
Recall Event ID 75828
Product Classification Tray, surgical, instrument - Product Code FSM
Product Synthes VA Implant Rack for the Compact Distal Radius System
Tray/Surgical/Instrument
Code Information Catalog ID (part # 60.119.012), Lot Number FL00528
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall
The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
FDA Determined
Cause 2
Process control
Action DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: Synthes5748@stericycle.com or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.
Quantity in Commerce 31 units
Distribution Nationwide Distribution
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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