FDA Device Intelligence
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Cutter, Surgical

FDA product code FZT · Class 1 · General, Plastic Surgery

1,228
Registered devices
607
Adverse events
6
Recalls
52
510(k) clearances

Devices with this code

Velofix™ PEEK Lumbar Cage — CG MedTech Co.,Ltd.SeaSpine Spacer System - Pacifica — Seaspine Orthopedics CorporationMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Arthrex® — ARTHREX, INC.Sklar — SKLAR CORPORATIONAmbler Surgical — AMBLER SURGICAL CORP.Reform Ti CT Modular MIS Pedicle Screw System — PRECISION SPINE, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Swann Morton Ltd. — SWANN-MORTON LIMITEDRegatta Lateral System — Seaspine Orthopedics CorporationSwann-Morton Limited — SWANN-MORTON LIMITEDL-Box® — INNO Holdings, Inc.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.SeaSpine Spacer System - Pacifica — Seaspine Orthopedics CorporationTimberline Lateral Fusion System — Highridge Medical, LLCTimberline Lateral Fusion System — Highridge Medical, LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.SeaSpine Spacer System - Pacifica — Seaspine Orthopedics CorporationSklar® — SKLAR CORPORATIONVelofix™ PEEK Lumbar Cage — CG MedTech Co.,Ltd.Response Spine System — ORTHOPEDIATRICS CORP.AESCULAP — Aesculap AG

Recent recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2010-06-04Maquet CardiovascularPouch integrity may be compromised, resulting in loss of sterility.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.