FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0943-03
- 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.
- Status
- Terminated
- Initiated
- 2002-12-11
- Posted
- 2003-06-21
- Terminated
- 2003-04-08
- 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 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K021324","K012967","K010988"]
- PMA numbers
- not on file
- Product code
- NDH
- Firm FEI
- 3003363248
- Firm city
- Cranbury
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28