HTR-PMI PM623280Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233026246), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
1 other recall cover devices cleared under the same FDA submission (K924935); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Depression1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Depression; No Known Impact Or Consequence To Patient
MAUDE report 10341401 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K924935. One submission often covers many models, so check the product and lot details in each record.
- Z-2751-2016 · Jun 13, 2016 · TerminatedHard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of
Other Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction devices
- OmniPore Surgical Implant OP7544Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9520Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9519Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP7543Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall0 reports
- Su-Por Surgical Implants 4353Poriferous, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction8 reports
- OmniPore Surgical Implant OP8330Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction3 reports
- HTR-PEKK PK620905Oxford Performance Materials, Inc. · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 reports
- OmniPore Surgical Implant OP8322Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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