Prosthesis, Chin, Internal
General, Plastic Surgery · 21 CFR 878.3550
Recent MDR events
240 adverse event reports on file
- MEDPOR PRIORITY CUSTOMIZED CRANIAL - XLJul 15, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00114
- FLOWERS MANDIBULAR GLOVEJun 26, 2026MalfunctionImplantech Associates, Inc.2028924-2026-00003
- MEDPOR CUSTOMIZED CRANIAL-LJun 2, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00073
- MEDPOR PRIORITY CUSTOMIZED MIDFACE AUGApr 23, 2026InjuryStryker Orthopaedics-mahwah0008010177-2026-00059
- SST EZ SPHERE - 20MMMar 30, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00046
- SST EZ SPHERE - 18MMMar 30, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00044
- SST EZ SPHERE - 18MMMar 30, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00045
- SST EZ SPHERE - 18MMMar 30, 2026MalfunctionStryker Orthopaedics-mahwah0008010177-2026-00043
- MEDPOR CUSTOMIZED CRANIAL-SMar 19, 2026InjuryStryker Orthopaedics-mahwah0008010177-2026-00036
- MEDPOR CUSTOMIZED-MIDFACEMar 19, 2026InjuryStryker Orthopaedics-mahwah0008010177-2026-00037
Event type breakdown
Recalls
5 recall events for this product code
- DSAART LLCOpen, ClassifiedDec 18, 2025
Brand Name: AART Chin Implant
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Z-0946-2026 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedFeb 11, 2015
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026
Potential for implant damage, implant cracking off/breaking intra-operatively.
Z-1090-2015 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedFeb 11, 2015
MEDPOR BARRIER Sheets Orbital Floor Implant
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Z-1091-2015 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedFeb 11, 2015
MEDPOR BARRIER Sheets Rectangle
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Z-1092-2015 · View FDA record ↗ - Implantech Associates IncTerminatedSep 17, 2013
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M.
Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.
Z-2211-2013 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Sterigenics U.s., Llc
Corona, CA, US
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Biomet Microfixation
Jacksonville, FL, US
Implantech Associates, Inc.
Ventura, CA, US
Eurofins Infinity Laboratory Group Inc.
San Jose, CA, US
Hanson Medical, Inc.
PASO ROBLES, CA, US
Sterigenics U.s., Llc
Atlanta, GA, US
510(k) clearances
66 clearances for this product code
- Stryker Leibinger GmbH & Co KGMar 12, 2026
K254233 · MEDPOR Customized Implant Kit
- Keosan Trading Co.Nov 22, 2023
K232593 · FITme Customized Silicone Implant
- Implantech Associates, Inc.Dec 23, 2020
K200610 · Customized Contour Implant
- Implantech Associates, Inc.Aug 23, 2019
K191130 · Customized Contour Implant
- Stryker Leibinger GmbH & Co KGAug 15, 2019
K191916 · Stryker CMF MEDPOR Priority Customized Implant Kit
- StrykerFeb 5, 2016
K153508 · Stryker CMF MEDPOR Customized Implant
- Poriferous, LLCJan 20, 2016
K152463 · SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
- StrykerMar 23, 2015
K143173 · Stryker CMF MEDPOR Customized Implant