Reported Apr 6, 2022 · Ongoing

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Howmedica Osteonics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm
  • Catalog Number6570-0-032
Lot codes and dates
  • Lot Numbers89648801 89648802 89648803 89648804 89648805
  • GTIN04546540608475 ****UPDATE 3/17/22:
  • Lot Number89648802
  • UDI" (01)04546540608475(17)261020(10)89648802
  • Removed from scope of Recall89648801 89648803 89648804 89648805
Amount recalled
92 units Update: 40 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.