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U.S. Department of Health and Human Services

Class 2 Device Recall GAP ENDOEXO MEDULLARY SYSTEM

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  Class 2 Device Recall GAP ENDOEXO MEDULLARY SYSTEM see related information
Date Initiated by Firm February 20, 2015
Date Posted April 02, 2015
Recall Status1 Terminated 3 on April 30, 2015
Recall Number Z-1362-2015
Recall Event ID 70630
510(K)Number K111232  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
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
Code Information Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Autoroute Chomedy
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144 Ext. 242
Manufacturer 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 Determined
Cause 2		 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 egarcia@pegamedical.com.
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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = PEGA MEDICAL INC.
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