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U.S. Department of Health and Human Services

Class 3 Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail) Hip Peg

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  Class 3 Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail) Hip Peg see related information
Date Initiated by Firm December 11, 2002
Date Posted June 21, 2003
Recall Status1 Terminated 3 on April 08, 2003
Recall Number Z-0943-03
Recall Event ID 25800
510(K)Number K010988  K012967  K021324  
Product Classification Nail, Fixation, Bone, Metallic - Product Code NDH
Product Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
Code Information Catalog # Lot # -- 4418080--PF02385;  PF02437;  PF02477;  PF02696;  PF02697;  PF02695;  PF02378;  PF02333;   4408080-- FP-1161;  FP-1094;  FP01176;  FP-1089;   4408081-- PF02333;   4418090-- PF02701;  PF02700;  PF02478;  PF02438;  PF02640;   4408101-- PF02335;   4418105-- PF02336;   4408111-- PF02193;   4418110-- PF02713;  PF02712;  PF02709;  PF02641;  PF02495;  PF02480;  PF02440;  PF02387;  PF02380;   4408110-- FP01175;  FP-1147;  FP-1097;  FP-1092;   4408090-- FP01179;  FP-1163;  FP-1095;  FP-1090;  271201;   4408091-- PF02192;   4418095-- PF02334;   4408100-- FP-1096;  FP-1091;  FP01178;  FP-1160;   4418100-- PF02335;  PF02707;  PF02371;  PF02379;  PF02386;  PF02439;  PF02479;  PF02703;  PF02705;  PF02706;   4418120-- PF02715;  PF02714;  PF02539;  PF02441;  PF02388;  PF02381;  PF02372;  PF02337;   4408120-- FP01177;  FP-1162;  FP-1098;  FP-1093;   4408121-- PF02337. 
Recalling Firm/
Manufacturer
Disc Orthopaedic Technologies Inc
101 Interchange Plaza
Cranbury NJ 085123716
For Additional Information Contact Mr. Tamir Kazaz
609-395-4172
Manufacturer Reason
for Recall
The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
FDA Determined
Cause 2
Other
Action The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.
Quantity in Commerce 1540
Distribution Product is manufactured at Disc-O-Tech Medical Technologies Ltd. located at 3 Hasadnaot St., Herzliya 46728, Israel. Product is then distributed to the rest of the world including the U.S.A. Products enter the U.S.A. through Port Elizabeth, New Jersey. The firm''s U.S.A. importer and distributor is Disc Orthopaedic Technologies, Inc., located at 101 Interchange Plaza, Cranbury, NJ 08512. Disc Orthopaedic Technologies, Inc., then distributes the product to their Agent Principles, employees of Disc Orthopaedic Technologies, Inc., throughout the U.S.A. Each agent principle then distributes the product to their sales representative who then sells the product to customers, primarily consisting of surgeons. Product is maintained with the sales representative and is only sold to a customer on an as needed basis. Customers do not have stock of product maintained at hospitals. Hospitals are located nationwide.
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 = NDH and Original Applicant = DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
510(K)s with Product Code = NDH and Original Applicant = DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
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