Home › Device types › GDZ
Handle, Scalpel
FDA product code GDZ · Class 1 · General, Plastic Surgery
1,721
Registered devices
128
Adverse events
13
Recalls
16
510(k) clearances
Devices with this code
FuzeFix Mini — FUSION ORTHOPEDICS, LLCHELMUT ZEPF — Helmut Zepf Medizintechnik GmbHAmbler Surgical — AMBLER SURGICAL CORP.Blade Handle — KATENA PRODUCTS, INC.V. Mueller — STERIS CORPORATIONQuinelato — Schobell Industrial LtdaNovo Surgical Inc. — NOVO SURGICAL, INC.comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.Gen2 — SURGIX MEDICAL LLCAESCULAP — Aesculap AGcomknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.Susol® Scalpel Handle No 3 (Pack of 10) — BAILEY INSTRUMENTS LTDSurgical Direct — Surgical Direct, Inc.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHenry Schein — HENRY SCHEIN, INC.HNM Medical — HNM STAINLESS, LLC.comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftPower Dental U.S.A., Inc. — Power Dental U.S.A. Inc.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONcomknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.BR Surgical, LLC — BR Surgical, LLCAESCULAP — Aesculap AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2022-09-02 | Steris Corporation | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a |
| 2016-03-11 | Integra York PA, Inc | One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handl |
| 2014-09-26 | Teleflex Medical | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. |
| 2014-06-24 | Bard Access Systems | Potential for inadvertent scalpel stick injury involving the safety scalpel. |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
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