Prosthesis, Chin, Internal
FDA adverse event reports and recall history for prosthesis, chin, internal (product code FWP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 239
- Deaths
- 1
- Injuries
- 191
- Malfunctions
- 37
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-18Open, ClassifiedNo Marketing Application
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
- 2015-02-11TerminatedProcess control
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Potential for implant damage, implant cracking off/breaking intra-operatively.
- 2015-02-11TerminatedProcess control
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
- 2015-02-11TerminatedProcess control
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
- 2013-09-17TerminatedNonconforming Material/Component
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
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.
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