Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
This recall has been terminated (originally issued February 16, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- January 27, 2014
- Posted
- February 16, 2014
- Terminated
- December 18, 2015
- Recall Number
- Z-0986-2014
- Quantity
- 1,132,096
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
Lot / Code Info
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.
Root Cause
Labeling Change Control
Action Taken
A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants.
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