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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 3.7mm and 5.0mm Dynamic Locking Screw (DLS)

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  Class 2 Device Recall Synthes 3.7mm and 5.0mm Dynamic Locking Screw (DLS) see related information
Date Initiated by Firm July 22, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-0390-2014
Recall Event ID 66666
510(K)Number K110592  
Product Classification Screw, fixation, bone - Product Code HWC
Product 3.7mm and 5.0mm Dynamic Locking Screw (DLS)

Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Code Information All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.
Quantity in Commerce 40248
Distribution Worldwide Distribution - USA (nationwide) and internationally to 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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = SYNTHES USA
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