Z-1362-2015 Class II Terminated
FDA device recall Z-1362-2015 was initiated by Pega Medical Inc. on February 20, 2015 and is designated Class II. Reason for recall: Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) … The recall status is terminated (terminated April 30, 2015). Affected quantity: 7 units distributed in the US;.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- February 20, 2015
- Termination Date
- April 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units distributed in the US;
Product Description
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
Reason for Recall
Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.
Distribution Pattern
US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
Code Information
Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;