C-Taper Head 06-2898Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327016284), received between Apr 16, 2019 and Oct 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K910988, K993601); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, RIGHT BIPOLAR HIP. IT WAS REPORTED THAT THE 28 -3 LFIT HEAD WOULD NOT LOCK ONTO THE OMNIFIT HFX STEM. THE SURGEON TRIED 3 TIMES. AS THE REP WENT TO PULL ANOTHER FEMORAL HEAD, THE SURGEON GAVE THE HEAD A THOROUGH CLEANING AND MADE 3 MORE ATTEMPTS. A 28 -2.5 C-TAPER BIOLOX HEAD WAS OPENED AND LOCKED ON TO THE SAME STEM AS EXPECTED. THE BIPOLAR COMPONENT WAS THEN IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216233 ↗
• MalfunctionApr 16, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, LEFT BIPOLAR HIP. IT WAS REPORTED THAT AFTER IMPACTING THE C-TAPER LFIT HEAD, THE HEAD WAS ABLE TO BE REMOVED FROM THE TRUNNION USING ONE FINGER. SURGEON REMOVED THE HEAD, CLEANED AND DRIED IT, RE-IMPACTED IT WITH THE SAME RESULT. A SECOND HEAD WAS OPENED AND PERFORMED AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. THE REP MIGHT BE ABLE TO OBTAIN THE OPERATIVE REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K910988, K993601. One submission often covers many models, so check the product and lot details in each record.

• Z-0390-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
• Z-0391-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
• Z-1822-2009 · Jun 18, 2009 · Terminated
  V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended f