Smith & Nephew Orthopaedics AG
AARAU Aargau, CH
SMITH & NEPHEW ORTHOPAEDICS AG appears in FDA device records in AARAU Aargau, CH. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613369 | 3002807893 | SMITH & NEPHEW ORTHOPAEDICS AG | SCHACHENALLEE 29, AARAU Aargau CH-5001 CH | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- JDQCerclage, Fixation
- FZOChisel, Surgical, Manual
- HXDClamp
- JDODevice, Fixation, Proximal Femoral, Implant
- HWAImpactor
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWHProsthesis, Toe, Constrained, Polymer
- HWCScrew, Fixation, Bone
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1133-2022 | INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right | Right nails were anodized, marked, and labelled as left nails and vice versa | Class II | Open, Classified | |
| Z-2827-2020 | POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide. | Multiple lots being recalled due to a product design issue | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain