DFS HA BONE SCREWS HAB60-16070Recalls & 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 other recall cover devices cleared under the same FDA submission (K081244, K992367); 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.

Recalls naming this device

1. Aug 21, 2019Terminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0528-2020 · Root cause: Environmental control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081244, K992367. One submission often covers many models, so check the product and lot details in each record.

• Z-1823-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Screw, fixation, bone.