| Class 3 Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail) Hip Peg |  |
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
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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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NDH 510(K)s with Product Code = NDH
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