Holder, Needle; Orthopedic
Orthopedic · 21 CFR 888.4540
Recent MDR events
114 adverse event reports on file
- TC RYDER NEEDLE HOLDERDELSERR 265MMFeb 26, 2026MalfunctionAesculap Ag9610612-2026-00038
- DUROGRIPFeb 23, 2026MalfunctionAesculap Ag24413578
- CLASSIC PLUS® NEEDLE HOLDER, CRILE-WOOD, 6 IN.Oct 21, 2025MalfunctionSymmetry Surgical Inc.3007208013-2025-00058
- SYMMETRY MAYO CLASSIC®Jul 15, 2025InjurySymmetry Surgical Inc.22505785
- SHARPSHOOTER HANDLEJul 15, 2025MalfunctionStryker Endoscopy-san Jose0002936485-2025-00642
- CLASSIC PLUS NEEDLE HOLDER, MAYO-HEGARJul 2, 2025InjurySymmetry Surgical Inc.3007208013-2025-00027
- DUROGRIP MAYO-HEGAR NEEDLE HOLDER 185MMJun 12, 2025MalfunctionAesculap Ag9610612-2025-00110
- CLASSIC PLUS NEEDLE HOLDER CRILE-WOOD, 6 INMay 29, 2025MalfunctionSymmetry Surgical Inc.3007208013-2025-00013
- NEEDLE HOLDERMay 1, 2025MalfunctionUnknownMW5169781
- SYMMETRY SURGICAL INC.Jun 28, 2024MalfunctionSymmetry Surgical Inc.3007208013-2024-00031
Event type breakdown
Recalls
5 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-0954-2025 · View FDA record ↗ - Aesculap Implant Systems LLCOpen, ClassifiedJul 14, 2023
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Z-2146-2023 · View FDA record ↗ - DePuy Orthopaedics, Inc.TerminatedJan 11, 2012
Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible po
DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.
Z-0508-2012 · View FDA record ↗ - Aesculap Implant Systems LLCTerminatedUnknown
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Z-1383-2022 · View FDA record ↗ - ArthroCare CorporationOpen, ClassifiedUnknown
Speed Stitch Needle Cassette
Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.
Z-2999-2020 · View FDA record ↗
Registered firms
250 firms currently registered for this product code
Isoaid, L.l.c.
PORT RICHEY, FL, US
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
G.a. Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Volgo Care International (private) Limited
Sialkot Punjab, PK
Mts Brothers Surgical Instruments
Punjab, PK
Zimmer Biomet Korea Ltd.
Seoul, KR
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Silver Plus Corp.
SIALKOT Punjab, PK
Towne Brothers (pvt.), Ltd.
SIALKOT Punjab, PK
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Buxton Biomedical, Inc.
EAST HANOVER, NJ, US
Ebner Medical Llc
Cincinnati, OH, US
Max Hauser Suddeutsche Chirurgiemechanik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
My Medical Store Llc
Fort Lauderdale, FL, US
Evonos Gmbh & Co. Kg
Tuttlingen Baden-Wurttemberg, DE
Laparomed Private Limited
Mumbai Maharashtra, IN
Huaian Frimen Co., Ltd
Huaian Jiangsu, CN
Kls Martin Malaysia Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
Sklar Corporation - Warehouse
Salisbury, MD, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
B-one Ortho Corp.
Fairfield, NJ, US
Novo Surgical, Inc.
Westmont, IL, US
Cislak Manufacturing, Inc.
NILES, IL, US
510(k) clearances
5 clearances for this product code
- Dhason Brothers, Inc.Feb 3, 1989
K890167 · HOLDER, NEEDLE
- Micrins Surgical, Inc.Aug 21, 1987
K872989 · MICRINS NEEDLE HOLDER
- Buckman Co., Inc.Feb 7, 1986
K860018 · FISCHER WIRE/PIN CLAMP
- Ace Orthopedic Manufacturing Co.Sep 9, 1980
K801594 · ACE FISCHER EXTERNAL FIXATION DEVICE
- Edward Weck, Inc.Jan 20, 1978
K772388 · CONVERSE-GILLIES NEEDLE HOLDER