Reported Sep 10, 2014 · Terminated

STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY

Pioneer Surgical Technology, 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: PIONEER SURGICAL TECHNOLOGY, INC. · 375 River Park Cir · Marquette, MI · 49855-1781

Is this the product you have?

  • STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Lot codes and dates
  • Lot numbers
    • 104875
    • 104876
    • 104877
    • 104878
    • 104879
    • 104880
    • 104881
    • 117030
    • 117031
    • 121947
    • 124260
Amount recalled
11 sets

Where it was sold

Why it was recalled

Some set screw thread profiles were found not to be within specifications.

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 30, 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.