Reported Jul 15, 2015 · Terminated

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX…

Synthes, Inc.

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: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417

Is this the product you have?

  • TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Lot codes and dates
    • Part # 04.004.000
    • lot # 7950994
Amount recalled
3

Where it was sold

Why it was recalled

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

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 Sep 15, 2015 · Data as of Sep 19, 6:53 PM UTC

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