Reported Oct 29, 2014 · Terminated

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

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?

    • DePuy Synthes Radiolucent Retractor
    • part number 387.580
    • lot number 3620715
Lot codes and dates
  • Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
Amount recalled
11

Where it was sold

Why it was recalled

Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

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 Dec 18, 2015 · Data as of Sep 19, 5:39 PM UTC

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