Recall Z-0986-2014— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2014-01-27, terminated 2015-12-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-27
- Terminated
- 2015-12-18
- Firm location
- West Chester, PA, United States
Product description
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Reason for recall
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.