OmniPore Surgical Implant OP7543Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K123908); 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.

Recalls naming this device

1. Jan 25, 2017Class IITerminated

   Mislabeling. The packaging labeled as left mandible contained a right mandible.

   Z-1382-2017 · Root cause: Other · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123908. One submission often covers many models, so check the product and lot details in each record.

• Z-1223-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
• Z-1224-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio