Washer, Bolt Nut
Arthrex, Inc.'s record for this product code
MDR events735All time
Recalls1All time
510(k) clearances16All time
Recent MDR events
735 adverse event reports on file
- Low-Profile AC Implant DeviceJul 31, 2026Malfunction1220246-2026-04141
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANJul 29, 2026Malfunction1220246-2026-04088
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANJul 27, 2026Malfunction1220246-2026-04033
- MINI TIGHTROPE IMPLANT WITH INSERTERJul 21, 2026Malfunction1220246-2026-03984
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 20, 2026Malfunction1220246-2026-03922
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 13, 2026Malfunction1220246-2026-03729
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 13, 2026Malfunction1220246-2026-03731
- K-LESS T-ROPE W/DRV, SYN REPR, TIJul 9, 2026Malfunction1220246-2026-03685
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 8, 2026Malfunction1220246-2026-03653
- SYNDESMOSIS TIGHTROPE PRO IMPLANT, TIJul 8, 2026Malfunction1220246-2026-03654
Recalls
1 recall events for this product code
510(k) clearances
16 clearances for this product code
- K253727Dec 22, 2025
Syndesmosis TightRope PRO
- K232755Oct 6, 2023
Arthrex FiberTape and TigerTape Cerclage Sutures
- K221485Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
- K220947Jun 6, 2022
Arthrex Knotless AC Repair Devices
- K213644Dec 17, 2021
Arthrex Knotless Mini TightRopes
- K201522Sep 3, 2020
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
- K140328Mar 10, 2014
CMC MINI TIGHTROPE
- K133275Jan 30, 2014
MINI TIGHTROPE
- K112437Dec 21, 2011
ARTHREX FRACTURE SYSTEM
- K090107Aug 6, 2009
MINI TIGHTROPE