Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0986-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 27, 2014

Date Posted: February 26, 2014

Recall Number: Z-0986-2014

Event ID: 67390

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,132,096

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.

Voluntary or Mandated:

Voluntary: Firm initiated