Gauge, Depth
Orthopedic · 21 CFR 888.4300
Recent MDR events
3,439 adverse event reports on file
- Depth Gauge f/Scr ø2+2.4 meas-range up-tJul 30, 2026MalfunctionSynthes Gmbh8030965-2026-07857
- 3.5 VOLT(TM) DEPTH GAUGE 6 TO 110MMJul 29, 2026MalfunctionSynthes Gmbh8030965-2026-07830
- 2.7/3.5MM DEPTH GAUGE 0 TO 60MMJul 28, 2026MalfunctionSynthes Gmbh8030965-2026-07786
- 2.4/2.7 VOLT(TM) DEPTH GAUGE 0 TO 90MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07540
- DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07569
- Depth Gauge f/Lock-Scr meas-range - 110Jul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07597
- Depth Gauge f/Scr ø1.3+1.5 SStJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07607
- QUICKSETJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12730
- 2.7 VOLT(TM) DEPTH GAUGE 0 TO 60MM CLOSEJul 21, 2026MalfunctionSynthes Gmbh8030965-2026-07409
- 2.4/2.7 VOLT(TM) DEPTH GAUGE 0 TO 90MMJul 21, 2026MalfunctionSynthes Gmbh8030965-2026-07411
Event type breakdown
Recalls
3 recall events for this product code
- Stryker Howmedica Osteonics Corp.TerminatedMar 31, 2011
Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325
Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.
Z-1862-2011 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 19, 2010
Depth Gauge; Catalog Number: 703707;
The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.
Z-0796-2010 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
DVR Crosslock ePAK Depth Gauge, Model Number 212000003
There is a potential for weak seals of the sterile packaging.
Z-1947-2019 · View FDA record ↗
Registered firms
378 firms currently registered for this product code
Rudischhauser Surgical Instruments Manufacturing Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Gauthier Biomedical, Inc.
Grafton, WI, US
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Bioretec Ltd.
Tampere Pirkanmaa, FI
Meditec Source Gmbh & Co. Kg
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Ldr Medical
Sainte-Savine Aube, FR
North Coast Medical, Inc.
Morgan Hill, CA, US
Jeil Medical Corporation
Seoul, KR
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Mack Molding Company
ARLINGTON, VT, US
Trigon America Llc
Aurora, IL, US
Micropulse Inc
Columbia City, IN, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Viant Medical, Llc
Fort Wayne, IN, US
Acumed Llc
Hillsboro, OR, US
Br Surgical Llc
Jacksonville, FL, US
Solco Biomedical Company India Private Limited
KADI Gujarat, IN
Orthofix Srl
BUSSOLENGO Verona, IT
Bradshaw Medical Inc.
Kenosha, WI, US
Xinhua Healthcare Industry Co.,limited
Zibo Shandong, CN
Arthrex Mexico, S.a. De C.v.
Col. Napoles Mexico, MX
Mahe Medical Usa
Laramie, WY, US
Merete Gmbh
BERLIN, DE
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Ortosistemas, S.a.
Panama, PA
510(k) clearances
4 clearances for this product code
- Acufex Microsurgical, Inc.Mar 23, 1994
K940480 · ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
- Acufex Microsurgical, Inc.Dec 29, 1992
K925335 · ACUFEX INTRA ARTICULAR MEASURING DEVICE
- Buckman Co., Inc.Sep 9, 1987
K873191 · ACROMED INTERBODY DEPTH GAUGES
- Cedar Surgical, Inc.Nov 26, 1986
K864426 · RAYLOR(TM) DEPTH GAUGE