Retractor, Self-retaining
Gastroenterology, Urology · 21 CFR 876.4730
Recent MDR events
86 adverse event reports on file
- SNAP CLAMP ASSEMBLYFeb 5, 2026MalfunctionIntegra Lifesciences Corporation Oh/usa3004608878-2026-00002
- BOOKLER TABLE MOUNTED RETRACTOR SYSTEMSSep 9, 2025MalfunctionFlexbar Machine Corporation23003971
- SKLAR®Apr 9, 2025MalfunctionSklar Corporation21804614
- MILTEX SELF-RETAINING RETRACTORJun 22, 2023InjuryJarit / Integra Lifesciences CorporationMW5118724
- STANDARD WISHBONE ASSEMBLYApr 19, 2023MalfunctionIntegra Lifesciences Corporation Oh/usa3004608878-2023-00071
- RETRACTOR, SELF-RETAININGOct 24, 2022MalfunctionSurgical Dynamics15657356
- LAPO-CLAMP IISep 21, 2022MalfunctionIntegra Lifesciences Corporation Oh/usa3004608878-2022-00191
- BALFOUR ABDOMINAL RETRACTOR 200X235MMMar 15, 2022MalfunctionAesculap Ag9610612-2022-00075
- GOSSET ABDOMINAL RETRACTOR MED 55MMSep 10, 2020MalfunctionAesculap Ag9610612-2020-00462
- GOSSET ABDOMINAL RETRACTOR MED 55MMAug 12, 2020MalfunctionAesculap Ag9610612-2020-00368
Event type breakdown
Recalls
3 recall events for this product code
- Sklar InstrumentsOpen, ClassifiedJan 16, 2025
ECONO STERILE medical procedure kits labeled as:
Reports of various packaging issues that may result in a breach of the sterile barrier.
Z-0929-2025 · View FDA record ↗ - Abeon Medical CorporationTerminatedUnknown
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY.
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Z-0684-2016 · View FDA record ↗ - Abeon Medical CorporationTerminatedUnknown
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA)
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Z-0685-2016 · View FDA record ↗
Registered firms
152 firms currently registered for this product code
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Stone Instruments Co.
SIALKOT Punjab, PK
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Cm Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Endo Tech Instruments
Sialkot Punjab, PK
Tontarra Medizintechnik Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Med Saver, Inc.
PHOENIXVILLE, PA, US
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Medical Bees Gmbh
Emmingen-Liptingen Baden-Wurttemberg, DE
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Bak Kohler Medical Kg
NEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, DE
Win Wings Corp.
SIALKOT Punjab, PK
Inka Surgical Instruments
Jandakot Western Australia, AU
Ambler Surgical, Llc
EXTON, PA, US
Surgix Medical Llc
Spring, TX, US
Hilbro International (pvt) Limited
SIALKOT Punjab, PK
Swantia Medical Private Limited
Sialkot Punjab, PK
Kls Martin Malaysia Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
Mattes Instrumente Gmbh
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Anmuth Medical International Llc
Beverly, MA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Fetzer Medical Gmbh & Co.kg
Tuttlingen Baden-Wurttemberg, DE
T.a. Walthem & Company
SIALKOT PUNJAB, PK
Aesculap, Inc.
CENTER VALLEY, PA, US
510(k) clearances
5 clearances for this product code
- Advanced Surgical Concepts (Asc)Dec 22, 1999
K993544 · SPACE-OR RETRACTOR
- Sur-Med Instruments, Inc.Jun 4, 1987
K870897 · KODNER ANAL PERIONEAL RETRACTOR
- Dantec Electronics, Inc.Apr 23, 1986
K860368 · URDYN 5000 (UROFLOWMETER)
- Dantec Electronics, Inc.Oct 4, 1985
K853119 · URODYN 1000
- The Kendal Co.Sep 20, 1985
K852083 · THE KENDALL URINARY OUTPUT MONITOR