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Class 2 Device Recall Synthes 3.2 mm Guide Wire 400mm |
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Date Initiated by Firm |
January 27, 2014 |
Date Posted |
February 16, 2014 |
Recall Status1 |
Terminated 3 on December 18, 2015 |
Recall Number |
Z-0986-2014 |
Recall Event ID |
67390 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product |
Synthes 3.2 mm Guide Wire 400mm.
Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral. |
Code Information |
part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333. |
Recalling Firm/ Manufacturer |
Synthes, Inc. 1302 Wrights Ln E West Chester PA 19380-3417
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For Additional Information Contact |
Customer Support 610-719-5000
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Manufacturer Reason for Recall |
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants. |
Quantity in Commerce |
1,132,096 |
Distribution |
Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland. |
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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