FDA Device recall Z-0986-2014
Synthes 3.2 mm Guide Wire 400mm
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Synthes 3.2 mm Guide Wire 400mm by Synthes, citing synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0986-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-27 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Reason
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Identifiers
| code_info | part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 70001…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0986-2014%22
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