Prosthesis, Finger, Constrained, Polymer
Orthopedic · 21 CFR 888.3230
Recent MDR events
492 adverse event reports on file
- TOUCH® CMC 1Jul 30, 2026InjuryKeri Medical Sa3009540749-2026-00008
- TOUCH® CMC 1Jul 30, 2026InjuryKeri Medical Sa3009540749-2026-00009
- KeriFlex MCP and PIP Finger Joint ProsthesisJul 27, 2026InjuryKeri Medical Sa3024706750-2026-00071
- TOUCH® CMC 1Jul 7, 2026InjuryKeri Medical Sa3009540749-2026-00005
- TOUCH® CMC 1Jul 7, 2026InjuryKeri Medical Sa3009540749-2026-00006
- KERIFLEX MCP AND PIP FINGER JOINT PROSTHESISJul 6, 2026InjuryKeri Medical Sa3024706750-2026-00063
- DJO SURGICALJul 2, 2026InjuryEncore Medical L.p.1644408-2026-01276
- DJO SURGICALJun 29, 2026InjuryEncore Medical L.p.1644408-2026-01242
- KERIFLEX MCP AND PIP FINGER JOINT PROSTHESISJun 24, 2026InjuryKeri Medical Sa3024706750-2026-00055
- DJO SURGICALJun 22, 2026InjuryEncore Medical L.p.1644408-2026-01208
Event type breakdown
Recalls
4 recall events for this product code
- Osteotec LimitedOpen, ClassifiedJul 31, 2025
Brand Name: Osteotec
There is the potential that the silicone implant may contain foreign material
Z-2222-2025 · View FDA record ↗ - Wright Medical Technology, Inc.TerminatedUnknown
SWANSON FINGER JOINT #1, Part Number 4700001
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Z-0570-2020 · View FDA record ↗ - Wright Medical Technology, Inc.TerminatedUnknown
SWANSON FINGER JOINT #2, Part Number 4700002
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Z-0571-2020 · View FDA record ↗ - Integra Lifesciences Sales LlcTerminatedUnknown
Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage:
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Z-0691-2020 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Mrpc
Butler, WI, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Statice Sa
BESANCON Doubs, FR
Keri Medical
Plan-les-Ouates Geneve, CH
Rms Co.
MINNEAPOLIS, MN, US
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Paragon Medical, Inc.
PIERCETON, IN, US
Osteotec Limited
Newbury West Berkshire, GB
Smith & Nephew, Inc.
Memphis, TN, US
Quality Tech Services, Llc
Shakopee, MN, US
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Clinical Polymer Technologies Ltd
Coalville Leicestershire, GB
Banister Tool, Inc.
Pflugerville, TX, US
Trimed, Inc.
Santa Clarita, CA, US
Depuy Mitek, Inc.
RAYNHAM, MA, US
Sterlab
VALLAURIS Alpes-Maritimes, FR
510(k) clearances
14 clearances for this product code
- Ascension Orthopedics, Inc.Dec 14, 2023
K233670 · Ascension Silicone MCP; Ascension Silicone PIP
- Brm Extremities SrlApr 4, 2023
K220142 · BRM Digitalis Spacer
- Keri Medical SAJul 27, 2022
K211385 · KeriFlex® MCP and PIP Finger Joint Prostheses
- Osteotec, Ltd.Apr 17, 2015
K140453 · OSTEOTEC SILICONE FINGER IMPLANT
- DePuy Orthopaedics, Inc.Feb 9, 2009
K083107 · MODIFICATION TO DEPUY NEUFLEX PIP FINGER
- Ascension Orthopedics, Inc.Jan 12, 2009
K082231 · ASCENSION SILICONE PIP
- Ascension Orthopedics, Inc.Nov 25, 2002
K022892 · ASCENSION SILLICONE MCP
- Avanta Orthopaedics, Inc.Jan 25, 2002
K013629 · FINGER JOINT PROSTHESIS