Component, Traction, Invasive
Orthopedic · 21 CFR 888.3040
Recent MDR events
298 adverse event reports on file
- DISTRACTIONOct 29, 2025InjuryKls Martin Se & Co. Kg9610905-2025-00090
- THREADED TUBE FOR PELVIC C-CLAMP IIJan 3, 2025MalfunctionSynthes Gmbh8030965-2025-00059
- UPPER SIDE ARM FOR PELVIC C-CLAMP IIApr 26, 2024MalfunctionSynthes Gmbh8030965-2024-05464
- LOWER SIDE ARM FOR PELVIC C-CLAMP IIApr 17, 2024MalfunctionSynthes Gmbh8030965-2024-05213
- THREAD-TUBE F/PELVIC C-CLAMPJun 15, 2023MalfunctionSynthes Gmbh8030965-2023-07487
- THREAD-TUBE F/PELVIC C-CLAMPJun 15, 2023MalfunctionSynthes Gmbh8030965-2023-07485
- LOWER SIDE ARM FOR PELVIC C-CLAMP IIMay 8, 2023MalfunctionSynthes Gmbh8030965-2023-05882
- OUTER RAIL FOR PELVIC C-CLAMP IIMay 8, 2023MalfunctionSynthes Gmbh8030965-2023-05883
- INNER RAIL FOR PELVIC C-CLAMP IIMay 8, 2023MalfunctionSynthes Gmbh8030965-2023-05885
- LONG CANNULATED NAIL FOR PELVIC C-CLAMP IIMay 8, 2023MalfunctionSynthes Gmbh8030965-2023-05887
Event type breakdown
Recalls
6 recall events for this product code
- Acumed LLCTerminatedMar 16, 2010
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref
Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
Z-1154-2010 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedSep 16, 2008
Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
Z-2080-2008 · View FDA record ↗ - Hand Biomechanics Lab IncTerminatedUnknown
Agee-WristJack Fracture Reduction System;
A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
Z-0136-2017 · View FDA record ↗ - Stryker GmbHTerminatedUnknown
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm
Pin To Rod Coupling could not clamp the pin and rod as intended
Z-0781-2020 · View FDA record ↗ - Ossur AmericasTerminatedUnknown
Ossur Skull Pin, Sterile Titanium Pin,
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Z-0997-2019 · View FDA record ↗ - Anjon HoldingsTerminatedUnknown
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provid
High rate of galling of one threaded component.
Z-2778-2020 · View FDA record ↗
Registered firms
156 firms currently registered for this product code
Hn And M Gmbh
Derendingen Solothurn, CH
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Sterigenics Us, Llc
Lewis Center, OH, US
Sterigenics U.s. Llc
MULBERRY, FL, US
Isomedix Operations Inc.
Sandy, UT, US
Stryker Gmbh
SELZACH Solothurn, CH
Depuy Spine, Inc.
RAYNHAM, MA, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Nutek Orthopaedics, Inc
Fort Lauderdale, FL, US
Medos International Sarl
Le Locle Neuchatel, CH
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Sterigenics Us Llc
Los Angeles, CA, US
Acumed Llc
Hillsboro, OR, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Stryker Sustainability Solutions
Tempe, AZ, US
Sterigenics U.s., Llc
Corona, CA, US
Isomedix Operations, Inc
ONTARIO, CA, US
Orthofix Srl
BUSSOLENGO Verona, IT
Zimmer Pte. Ltd.
Singapore South East, SG
Stryker Sustainability Solutions Phoenix
Phoenix, AZ, US
510(k) clearances
85 clearances for this product code
- Arbutus Medical, Inc.Apr 23, 2021
K203605 · SteriTrak
- Anjon Holdings, LLCMar 2, 2020
K193256 · Anjon Bremer Halo System
- Virak Orthopedics, LLCOct 10, 2019
K192465 · DigiFix Sterile Kit
- Hand Biomechanics Lab, Inc.Oct 22, 2018
K181192 · PIP Fix
- Anjon Holdings, LLCMar 19, 2018
K171863 · Anjon Bremer Halo System
- Surgical Instrument Service and Savings, Inc.Dec 28, 2016
K163028 · Medline ReNewal Reprocessed Stryker External Fixation Devices
- Virak Orthopedic Research, LLCJan 10, 2014
K132731 · DIGIFIX EXTERNAL FIXATION SYSTEM
- Stryker Corp.Jan 14, 2011
K102885 · HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX