Table, Surgical With Orthopedic Accessories, Manual
General, Plastic Surgery · 21 CFR 878.4950
Recent MDR events
79 adverse event reports on file
- SPICA TABLE ASSEMBLYJun 19, 2026MalfunctionOrthopediatrics3006460162-2026-00029
- TELIGEN TABLE MOUNT ADAPTER FORKOct 6, 2023MalfunctionDepuy Spine Inc1526439-2023-01945
- TELIGEN TABLE MOUNT ADAPTER KNOBOct 6, 2023MalfunctionDepuy Spine Inc1526439-2023-01944
- RYCOR HAND TABLEAug 3, 2021MalfunctionRycor12266780
- SCHAERER 7300Mar 20, 2020MalfunctionSchaerer9859825
- ADVANCED CONTROL I-BASE, DCMay 7, 2019MalfunctionMizuho Orthopedic Systems, Inc.8586190
- FOOT TRACTION BOOT TO ORTHOVISION TABLEJun 21, 2018MalfunctionSteris Corporation - Montgomery1043572-2018-00050
- A JACKSON SPINAL TABLEMay 29, 2018InjuryMizuho Orthopedic Systems, Inc.MW5077515
- STERIS OT-1100 FRACTURE TABLEJan 16, 2018Steris Corp.MW5074597
- TABLE, SURGICALDec 1, 2017MalfunctionSkytron, Inc.7074353
Event type breakdown
Recalls
11 recall events for this product code
- Trumpf Medical Systems, Inc.TerminatedNov 18, 2013
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Z-0342-2014 · View FDA record ↗ - Tenet Medical Engineering IncTerminatedFeb 26, 2008
TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M
Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
Z-0577-2008 · View FDA record ↗ - Tenet Medical Engineering IncTerminatedFeb 26, 2008
TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4
Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
Z-0578-2008 · View FDA record ↗ - Tenet Medical Engineering IncTerminatedFeb 26, 2008
TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M
Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
Z-0579-2008 · View FDA record ↗ - Smith & Nephew, Inc. Endoscopy DivisionTerminatedSep 30, 2006
Smith & Nephew Hip Positioning System Ref: 72200624 with System Components:
The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure
Z-1514-06 · View FDA record ↗ - Schaerer Medical USA IncTerminatedUnknown
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replace
The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Z-0371-2017 · View FDA record ↗ - Schaerer Medical USA IncTerminatedUnknown
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118.
The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Z-0372-2017 · View FDA record ↗ - Allen Medical SystemsTerminatedUnknown
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Z-0641-2018 · View FDA record ↗ - Allen Medical SystemsTerminatedUnknown
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Z-0642-2018 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
The 2nd Assist Knee Positioner
Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
Z-0803-2018 · View FDA record ↗
Registered firms
43 firms currently registered for this product code
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
Mammon International Corp.
TAIPEI CITY, TW
Sterigenics Us Llc
Grand Prairie, TX, US
Medos International Sarl
Le Locle Neuchatel, CH
Jorg & Sohn Gmbh
Ahorn-Schorkendorf Bavaria, DE
Millennium Surgical Corp
Schaumburg, IL, US
Galaxy India
NEW DELHI, IN
Viant Medical, Llc
Fort Wayne, IN, US
United Surgical Industries
SAHIBABAD Uttar Pradesh, IN
Jakutec Medizintechnik Gmbh & Co. Kg
LIPTINGEN Baden-Wurttemberg, DE
Stryker Endoscopy
SAN JOSE, CA, US
Guenter Stoffel Medizintechnik Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Syntec Scientific Corp.
CHANG HUA Changhua, TW
Depuy Mitek, Inc.
RAYNHAM, MA, US
Hebei Ruinuo Medical Instrument Co Ltd
Shijiazhuang Hebei, CN
Depuy Spine, Inc.
RAYNHAM, MA, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Globus Medical, Inc.
AUDUBON, PA, US
Orthopediatrics, Corp
Warsaw, IN, US
Cardinal Health 200, Llc
Waukegan, IL, US
White Surgical, Inc.
Fort Wayne, IN, US
A.m. Surgical, Inc.
Nashua, NH, US
Domico Med-device, Llc
Fenton, MI, US
General Hospital Supply Corp.
Indian Trail, NC, US
Sterigenics U.s., Llc
Charlotte, NC, US
510(k) clearances
13 clearances for this product code
- American Sterilizer Co.Mar 6, 1991
K905816 · ORTHOVISION TABLE
- Scholten Surgical Instruments, Inc.Mar 1, 1990
K900405 · SCHOLTEN FRAME
- Ortho-J, Inc.May 26, 1989
K891917 · ORTHO-J, INC. BEK-JS-004
- Arthro-Medic, Inc.May 23, 1989
K891387 · WILLIAMS BELT & BOOT
- Instrumentation Specialties, Inc.Apr 6, 1988
K881101 · K ORTHOPEDIC TABLE
- Orthopedic Systems, Inc.Mar 15, 1988
K880263 · OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
- Stierlen-Maquet AGSep 17, 1987
K873274 · PLASTER TABLE 1418
- Stierlen-Maquet AGSep 17, 1987
K873276 · EXTENSION DEVICE 1416