Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1362-2015 — 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 p

U.S. FDA — Device Enforcement · Canada · 2015-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1362-2015
Date of alert: 2015-02-20
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Pega Medical Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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