Z-0409-2014 Class II Terminated
FDA device recall Z-0409-2014 was initiated by Synthes USA HQ, Inc. on Jul 30, 2013 and is designated Class II. Reason for recall: The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number. The recall status is terminated (terminated Aug 31, 2015). Affected quantity: 13.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 30, 2013
- Termination Date
- Aug 31, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
Product Description
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Reason for Recall
The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
Distribution Pattern
Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
Code Information
Part No. 02.001.324, lot no. 6900823