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 |
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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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510(K) Database | 510(K)s with Product Code = HWC
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