Washer, Bolt Nut
Orthopedic · 21 CFR 888.3030
Recent MDR events
1,494 adverse event reports on file
- Low-Profile AC Implant DeviceJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04141
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANJul 29, 2026MalfunctionArthrex, Inc.1220246-2026-04088
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANJul 27, 2026MalfunctionArthrex, Inc.1220246-2026-04033
- MINI TIGHTROPE IMPLANT WITH INSERTERJul 21, 2026MalfunctionArthrex, Inc.1220246-2026-03984
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 20, 2026MalfunctionArthrex, Inc.1220246-2026-03922
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 13, 2026MalfunctionArthrex, Inc.1220246-2026-03729
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 13, 2026MalfunctionArthrex, Inc.1220246-2026-03731
- K-LESS T-ROPE W/DRV, SYN REPR, TIJul 9, 2026MalfunctionArthrex, Inc.1220246-2026-03685
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 8, 2026MalfunctionArthrex, Inc.1220246-2026-03653
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 8, 2026MalfunctionArthrex, Inc.1220246-2026-03654
Event type breakdown
Recalls
4 recall events for this product code
- TriMed Inc.Open, ClassifiedFeb 7, 2023
RipCord Syndesmosis Button, REF: STA001K
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Z-1101-2023 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedNov 26, 2013
Synthes Spiked Washers 13.5/6.5
During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
Z-0394-2014 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0338-2020 · View FDA record ↗ - Arthrex, Inc.TerminatedUnknown
Arthrex Suture Washer
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Z-2918-2016 · View FDA record ↗
Registered firms
840 firms currently registered for this product code
Acumed Llc
Hillsboro, OR, US
Life Science Outsourcing, Inc.
Brea, CA, US
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Lynx Medical Nj
Franklin, NJ, US
Ortosistemas, S.a.
Panama, PA
Farmaco Quimica Nacional, S.a.
La Esperilla Santo Domingo, DO
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Arthrex, Inc.
Naples, FL, US
Medical Surgical, Inc.
Andover, MN, US
Mahe Medical Usa
Laramie, WY, US
Hg Medical Gmbh
Raisting Bavaria, DE
Synthes (usa) Products Llc
West Chester, PA, US
Stryker Gmbh
SELZACH Solothurn, CH
Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti
Maltepe Istanbul, TR
Isomedix Operations Inc.
S Plainfield, NJ, US
Tornier Inc.
Columbia City, IN, US
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Vilex Llc
MCMINNVILLE, TN, US
I.t.s. Gmbh
LASSNITZHOEHE Steiermark, AT
Biotec Biotecnologias De Centroamerica S.a.
Rohrmoser San Jose, CR
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Arthrex Mexico, S.a. De C.v.
Col. Napoles Mexico, MX
Arthrex Japan G.k. (shinjuku)
Shinjuku-ku Tokyo, JP
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
510(k) clearances
93 clearances for this product code
- Movmedix S.A.S.Jun 10, 2026
K253115 · LARS ACJ
- Lincotek MedicalMar 27, 2026
K252081 · SportLinc Syndesmosis Device
- Arthrex, Inc.Dec 22, 2025
K253727 · Syndesmosis TightRope PRO
- Wright Medical Technology, Inc. (Stryker Corporation)Oct 29, 2025
K251643 · Synchfix EVT
- TriMed, Inc.Jul 11, 2025
K251134 · RipCord
- Acumed, LLCJan 23, 2025
K243624 · Acu-Sinch Knotless Mini
- Fusion OrthopedicsDec 23, 2024
K242091 · Bolo Button System
- Vilex, LLCNov 27, 2024
K243408 · TACTIX Vector Syndesmosis System