ATEC Lateral Navigation Disc Prep Instruments 267-01-000-10-NRecalls & 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, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K223765); 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 2, 2026Class IIOpen, Classified

   Due a design issue where the navigated array connection geometry is incorrect.

   Z-1343-2026 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223765. One submission often covers many models, so check the product and lot details in each record.

• Z-1342-2026 · Jan 2, 2026 · Open, Classified
  ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are int