Z-1362-2015Class II

GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18...

Name: Z-1362-2015 GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18...
Creator: Pega Medical Inc.
Published: 2015-02-20
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2015-02-20 / Terminated

FDA source

Pega Medical Inc. began a recall of 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... on 2015-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1362-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Posted: 2015-04-02
Terminated: 2015-04-30
Recalling firm: Orthopediatrics Canada ULC
Product: 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
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
FDA 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 consequences to the patient. In cases where consolidation has not been achieved after six weeks, replacement of the nail might be necessary. 3. All surgeons receiving this notice must acknowledge reception by a written confirmation sent to the distributor or to the contact reference person indicated below. US consignees with questions can call Pega Medical at 450-688-5144 ext. 242, or send fax to 450-688-1977, or send email to [email protected].
Quantity in commerce: 7 units distributed in the US;
Distribution: US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
Product codes and lots: Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1362-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1362-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-01

Product code HSB

K111232Class IIGap Endo-Exo Medullary SystemPega Medical, Inc. / cleared 2012-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)