Implant, Malar
General, Plastic Surgery · 21 CFR 878.3550
Recent MDR events
61 adverse event reports on file
- COMBINED SUBMALAR SHELLJul 16, 2026InjuryImplantech Associates, Inc.2028924-2026-00004
- BREAST IMPLANTMay 25, 2022InjuryUnkMW5109919
- BINDER SUBMALAR (R)Aug 4, 2021InjuryImplantech Associates, Inc.2028924-2021-00004
- OMNIPORE CUSTOMIZED SURGICAL IMPLANTMar 26, 2020InjuryMatrix Surgical Usa3009383407-2020-00002
- HANSON MEDICAL MALAR IMPLANTJun 28, 2019InjuryHanson Medical Inc2031444-2019-00001
- OMNIPORE SURGICAL IMPLANTMay 17, 2019InjuryMatrix Surgical Usa3009383407-2019-00005
- VITEK PROPLASTNov 13, 2018DeathUnkMW5081187
- CONFORM BINDER SUBMALAR (R)Jun 22, 2018InjuryImplantech Associates Inc.2028924-2018-00006
- BINDER SUBMALAR (R) IMPLANTOct 6, 2017InjuryImplantech Associates, Inc.2028924-2017-00006
- COMPOSITE¿ EPTFE-COATED FLOWERS DORSAL NASALAug 25, 2017InjuryImplantech Associates, Inc.2028924-2017-00005
Event type breakdown
Recalls
4 recall events for this product code
- DSAART LLCOpen, ClassifiedDec 18, 2025
Brand Name: AART Malar Implant
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Z-0947-2026 · View FDA record ↗ - Spectrum Designs IncTerminatedAug 29, 2007
Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.
Z-1206-2007 · View FDA record ↗ - Spectrum Designs IncTerminatedUnknown
Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BA
Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.
Z-1264-2007 · View FDA record ↗ - Spectrum Designs IncTerminatedUnknown
Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144
Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants
Z-1265-2007 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Eagle Medical Packaging Sterilization, Inc.
PASO ROBLES, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Biomet Microfixation
Jacksonville, FL, US
Hanson Medical, Inc.
PASO ROBLES, CA, US
Implantech Associates, Inc.
Ventura, CA, US
Surgical Technology Laboratories Inc.
Lugoff, SC, US
Eurofins Infinity Laboratory Group Inc.
San Jose, CA, US
Dsaart, Llc
Carson City, NV, US
510(k) clearances
40 clearances for this product code
- Aesthetic and Reconstructive Technologies, Inc.Jul 2, 2002
K021419 · AART MALAR IMPLANT
- Implantech Associates, Inc.Nov 24, 2000
K002886 · IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
- Pillar Surgical, Inc.Nov 22, 1999
K992240 · PILLAR MALAR IMPLANT
- Surgical Technology Laboratories, Inc.Nov 20, 1998
K983756 · SURGIFORM ANATOMICAL MALAR
- Seare Biomedical Corp.Sep 30, 1998
K982763 · SEARE BIOMEDICAL MALAR IMPLANTS
- Silimed, LLCJul 9, 1998
K981835 · SILIMED MALAR IMPLANT
- Spectrum Designs, Inc.Mar 3, 1998
K980139 · SPECTRUM DESIGNS PROFILE MALAR IMPLANT
- Spectrum Designs, Inc.Mar 3, 1998
K980141 · SPECTRUM DESIGNS PROJECTION MALAR IMPLANT