Pin, Fixation, Threaded
Orthopedic · 21 CFR 888.3040
Recent MDR events
2,172 adverse event reports on file
- Digit WidgetJul 27, 2026InjuryHand Biomechanics Lab2919128-2026-00005
- HALF PIN, SB, ORTHEX 4.0X150X30 BUTTON, HAJul 21, 2026MalfunctionOrthopediatrics3006460162-2026-00036
- DIGIT WIDGETJun 12, 2026InjuryHand Biomechanics Lab2919128-2026-00004
- 3.2MM TROCARMay 5, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-00611
- DIGIT WIDGETApr 16, 2026InjuryHand Biomechanics Lab2919128-2026-00003
- DIGIT WIDGETMar 17, 2026InjuryHand Biomechanics Lab2919128-2026-00002
- TI HALF PIN, LB, ORTHEX 5.0X250X20 HAMar 3, 2026MalfunctionOrthopediatrics3006460162-2026-00009
- OSTEOTITE BONE SCREW 220/40 MM SHAFT D 6 MM THREAD D 6-5 MMFeb 5, 2026InjuryOrthofix Srl9680825-2026-00008
- DIGIT WIDGETJan 30, 2026InjuryHand Biomechanics Lab2919128-2026-00001
- PROCALLUS SHORT CENTRAL BODYDec 16, 2025MalfunctionOrthofix Srl9680825-2025-00053
Event type breakdown
Recalls
100 recall events for this product code
- Musculoskeletal Transplant Foundation, Inc.TerminatedJul 24, 2015
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
Z-2210-2015 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
PELVIS PIN, REF 71366302, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1721-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1722-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
SMALL JOYSTICK THREADED PIN, REF 71173396, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1723-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
LARGE JOYSTICK THREADED PIN, REF 71173339, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1724-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1725-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1726-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1727-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1728-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedJun 6, 2012
4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Z-1729-2012 · View FDA record ↗
Registered firms
450 firms currently registered for this product code
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Arthrex, Inc.
Naples, FL, US
Quintus, Inc.
Camp Verde, AZ, US
Zimmer, Inc.
WARSAW, IN, US
Onyx Medical Llc
MEMPHIS, TN, US
Mahe Medical Usa
Laramie, WY, US
Odyssey Medical Technologies, Llc
Bartlett, TN, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Jabil Inc. (elmira)
Horseheads, NY, US
Arthrex, Inc.
Ave Maria, FL, US
Spitrex Orthopedics Switzerland Sa
Le Locle Neuchatel, CH
Teleflex Llc (nadc)
Olive Branch, MS, US
Smith & Nephew, Inc.
Memphis, TN, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
B & J Medical Llc
Kendallville, IN, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Synthes (usa) Products Llc
West Chester, PA, US
Aike (shanghai) Medical Instrument Co., Ltd.
Shanghai, CN
Biomet, Inc.
WARSAW, IN, US
Manufacturing Technology And Services, Llc
Oxford, AL, US
Viant Medical, Llc
Fort Wayne, IN, US
Steris Isomedix Puerto Rico, Inc.
Alts De Cerro Gordo 3&4, PR, US
Sterigenics Us, Llc
Lewis Center, OH, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
510(k) clearances
94 clearances for this product code
- Biodynamik, Inc.Feb 10, 2026
K260073 · XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
- Meduloc, LLCOct 29, 2025
K250316 · Meduloc Intramedullary Fracture Fixation (IFF) System
- Biodynamik, Inc.Jan 22, 2025
K241357 · XT3 System
- Smith & Nephew, Inc.Dec 8, 2022
K223112 · MAVERICK Mini External Fixation System
- Smith & Nephew, Inc.Feb 11, 2022
K213874 · MAVERICK External Fixation System
- Stryker GmbHOct 5, 2021
K211508 · Steinmann Pins and Kirschner Wires
- Smith & Nephew, Inc.Apr 2, 2021
K210784 · Extended HA Half Pins
- Syntec Scientific CorporationMay 5, 2020
K200933 · Syntec Non-Sterile Steinmann Pins System