NA 01-003-10-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862267139), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K140674, K162732, K182462); 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.

• MalfunctionAug 16, 2023Break; Break

  AS REPORTED, DURING SURGICAL USE A PIECE OF THE STEM EXTRACTOR INSTRUMENT BROKE WHILE TRYING TO EXTRACT THE STEM. THE BROKEN PIECE FELL ONTO THE DRAPE AND WAS RETRIEVED. SURGEON HAD TO SWITCH TO A ANOTHER STYLE EXTRACTOR WHICH CAUSE MINIMAL INCREASE IN SURGICAL TIME. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR PHOTOS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17554882 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140674, K162732, K182462. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2018 · Oct 9, 2017 · Terminated
  Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals underg