Novation 167-01-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862036018), received between Nov 8, 2022 and Nov 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080980); 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SPRINGS ON THE LOCKING MECHANISM OF THE BROACH HANDLE HAVE BROKEN. THIS HAS HAPPENED OVER TIME BY HEAVY STRIKES WITH THE MALLET AND CARELESS BEHAVIOR IN CENTRAL STERILE. THE SPRINGS AND LOCKING MECHANISMS ARE DAMAGED ON THE HANDLES. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080980. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2016 · Sep 23, 2015 · Terminated
  Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation