Reported Jun 5, 2013 · Terminated

Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball…

Orthopedic Alliance LLC

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: Orthopedic Alliance LLC · 26157 Jefferson Ave · Murrieta, CA · 92562-9561

Is this the product you have?

    • Ball Head
    • 28 Short CERAMIC Ball Head
    • 28 Medium CERAMIC Ball Head
    • 28 Long CERAMIC Ball Head
    • 32 Short CERAMIC Ball Head
    • 32 Medium CERAMIC Ball Head
    • 32 Long CERAMIC Ball Head
    • 28 Short CoCr Ball Head
    • 28 Medium CoCr Ball Head
    • 28 Long CoCr Ball Head
    • 28 X-Long CoCr Ball Head
    • 28 XX-Long CoCr Ball Head
    • 32 Short Ball Head
    • 32 Medium Ball Head
    • 32 Long
Lot codes and dates
  • Part No.
    • 194.01.28
    • 194.02.28
    • 194.03.28
    • 195.01.32
    • 195.02.32
    • 195.03.32
    • 188.01.28
    • 188.02.28
    • 188.03.28
    • 188.04.28
    • 188.05.28
    • 189.01.32
    • 189.02.32
    • 189.03.32
Amount recalled
26 units

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

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

Notice updated Mar 26, 2014 · Data as of Sep 19, 4:49 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.