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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Small Notch Titanium Reconstrcutive Plate

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  Class 2 Device Recall Synthes Small Notch Titanium Reconstrcutive Plate see related information
Date Initiated by Firm January 27, 2014
Date Posted March 11, 2014
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-1174-2014
Recall Event ID 67391
510(K)Number K915818  
Product Classification Plate, fixation, bone - Product Code HRS
Product Synthes Small Notch Titanium Reconstructive Plate

Product Usage:
The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Code Information All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
FDA Determined
Cause 2		 Labeling design
Action Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. .
Quantity in Commerce 18747
Distribution USA 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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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