Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082. 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.
FDA Recall Z-0359-2010 · Posted 2010-05-12
Recalling FirmOrthopediatrics Corp
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-07-21
Date Terminated2010-10-25
Product Quantity23 of all products
Reason for Recall
The potential exists for the nails to fracture during insertion of the nail.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.