Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.
- Company
- Orthopediatrics Corp
- Recall Initiated
- July 21, 2009
- Posted
- May 12, 2010
- Terminated
- October 25, 2010
- Recall Number
- Z-0362-2010
- Quantity
- 23 of all products
- Firm Location
- Warsaw, IN
Reason for Recall
The potential exists for the nails to fracture during insertion of the nail.
Distribution
Nationwide.
Lot / Code Info
Lots 105483 and 105484.
Root Cause
Device Design
Action Taken
Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.
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