Recall Z-1362-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Pega Medical Inc.
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 com
| Date | Apr 2, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Pega Medical sent the Urgent Field Safety Notice-Recall/Advisory Notice letter, dated 2015/02/20, to US consignees (surgeons) via email. The following actions were advised: 1. It is recommended to monitor patients as considered necessary in order to ensure that weight bearing does not take place until full consolidation of the fracture/osteotomy is completed and that weight bearing is applied progressively. 2. Report to the distributor or Pega Medical any adverse event observed. In cases where the consolidation has occurred, normal patient follow up can be continued with no serious conseq |
| Quantity | 7 units distributed in the US; |
| Distribution | US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc., Jan 26, 2012 |