510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0943-03

Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths...

Disc Orthopaedic Technologies Inc / initiated 2002-12-11 / Terminated
FDA source (opens on fda.gov)

Disc Orthopaedic Technologies Inc began a recall of Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm... on . The reason FDA records is "The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0943-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Disc Orthopaedic Technologies Inc
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.
Product code
NDH Nail, Fixation, Bone, Metallic
Reason for recall
The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
FDA root cause
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.
Product codes and lots
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.