Reported Jan 20, 2016 · Terminated

AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16…

Encore Medical, LP

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: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445

Is this the product you have?

  • AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Lot codes and dates
    • 178881L05
    • 178881L06
    • 183345L03
    • 178881L09
    • 178881L10
    • 183345L05
    • 178881L11
    • 178881L12
    • 183345L06
Amount recalled
23 units

Where it was sold

Why it was recalled

The trial shell mating feature on the broach is undersized.

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 1, 2016 · Data as of Sep 19, 6:02 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.