Recall Z-0943-03 ยท NDH Nail, Fixation, Bone, Metallic
Disc Orthopaedic Technologies Inc
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.
| Date | Jun 21, 2003 (initiated Dec 11, 2002) |
| Status | Terminated |
| Reason | The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010988 | FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM Disc-O-Tech Medical Technologies, Ltd., Jun 19, 2001 |
| K012967 | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM Disco-O-Tech Medical Technologies, Ltd., Oct 4, 2001 |
| K021324 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) Disco-O-Tech Medical Technologies, Ltd., May 23, 2002 |