HTR-PMI PM619689Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036235734), received between Mar 8, 2019 and Mar 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2019Device Handling Problem; Device Handling Problem

  THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 8403691 ↗
• InjuryMar 8, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Laceration(s)

  MAUDE report 8403636 ↗

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 · Terminated
  Hard 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