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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 3.2 mm Guide Wire 400mm

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  Class 2 Device Recall Synthes 3.2 mm Guide Wire 400mm see related information
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
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
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
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
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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