C-Taper Head 6001-2810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327016543), received between Dec 28, 2018 and Dec 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K900836, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WHEN THE METAL HEAD 6001-2810 IS PRESSED INTO DUAL MOBILE UH1-46-28 INTROPERATIVELY,HEAD CAN'T MOVE FREELY WITHOUT PUSHING WITH HAND HARD. CLUNK OCCURS WHEN MOVING. MAYBE THESE TWO MODELS CAN'T BE USED AND NEEDED CHANGING. EVENT UPDATE FROM (B)(6) 2018: SURGICAL DELAY IS NEARLY 1 HOUR. THE SURGEON SPENT NEARLY 20 MINUTES TO FIND ROOT CAUSE. AND THEN, THE SURGEON USED NEARLY 40 MINUTES TO CONFIRM THE FINAL REPLACEMENTS SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900836, 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