Home › Device types › HXI
Passer, Wire, Orthopedic
FDA product code HXI · Class 1 · Orthopedic
524
Registered devices
291
Adverse events
8
Recalls
3
510(k) clearances
Devices with this code
Vilex Guidewire — VILEX IN TENNESSEE, INC.Vilex Power Accessory — VILEX IN TENNESSEE, INC.LineSider — Highridge Medical, LLCN/A — BIOMET MICROFIXATION, INCDigiFuse Cannulated Intramedullary Fusion — Smith & Nephew, Inc.R3ACT Stabilization System — Paragon 28, Inc.CoLink Mfx — In2Bones USA, LLCSurgical Instruments — Smith & Nephew, Inc.STERILE .010 NITINOL WIRE — Biomet Orthopedics, LLCBioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc.TITAN™ — Ascension Orthopedics, Inc.Facet Screw System — PRECISION SPINE, INC.Lesser Metatarsal Shortening System — Paragon 28, Inc.Vilex Guidewire — VILEX IN TENNESSEE, INC.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.In2Bones — In2Bones USA, LLCIntegra® — Ascension Orthopedics, Inc.Vilex Guidewire — VILEX IN TENNESSEE, INC.NA — Integrity Implants Inc.Integra®Ti6® — Ascension Orthopedics, Inc.Guide Wire Kit, 3.0/3.5/4.0/4.5 Cannulated Screws — FLOWER ORTHOPEDICS CORPORATIONPrecision MIS Bunion System — Paragon 28, Inc.SAMPEDRO — INDUSTRIAS MEDICAS SAMPEDRO S A STIBIAXYS Ankle Fusion Plating System — Smith & Nephew, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Paragon 28, Inc. | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| 2016-05-20 | Integra LifeSciences Corp. | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-w |
| 2013-01-10 | Extremity Medical LLC | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw leng |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
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