Z-0408-2014 Class II Terminated
FDA device recall Z-0408-2014 was initiated by Synthes USA HQ, Inc. on Jul 31, 2013 and is designated Class II. Reason for recall: There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery. The recall status is terminated (terminated Jun 1, 2015). Affected quantity: 166.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- Jun 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 166
Product Description
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Reason for Recall
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
Distribution Pattern
USA Nationwide Distribution
Code Information
Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691