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Recall Observatory FDA recall evidence

Device product

Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.

Z-0986-2014

January 27, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 67390
Status
Terminated
Classification
Class II
Quantity
1,132,096
Official record key
device-enforcement:Z-0986-2014

Official wording

Reason: Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

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.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.