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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 Recall
Synthes 3.2 mm Guide Wire 400mm
see related information
Date Posted February 16, 2014
Recall Status1 Open
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, Pennsylvania 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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