HTR-PMI PM619842Recalls & 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 00841036238414), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Unspecified Infection
MAUDE report 8396582 ↗
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 Prosthesis, Chin, Internal devices
- MEDPOR 5444-0-310Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL6 reports
- MEDPOR 5444-0-510Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 5444-0-410Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 82007Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 5444-0-110Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 reports
- MEDPOR 5444-4-310Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 reports
- Conform™ Extended Anatomical Chin Size: MediumImplantech Associates, Inc. · Prosthesis, Chin, Internal3 reports
- MEDPOR 80010Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 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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