Reported Jun 10, 2015 · Terminated

3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm…

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?

  • 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Lot codes and dates
  • Part Number 310.65 310.67 310.221 lot numbers
    • PE00966
    • PE01000
    • PE01039
    • PE01058
    • PE00959
    • PE00968
    • PE00974
    • PE00998
    • PE01006
    • PE01011
    • PE01048
    • PE00971
    • PE01059
    • PE01040
Amount recalled
1495 US (37 OUS)

Where it was sold

  • Nationwide

Why it was recalled

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

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 Aug 18, 2016 · Data as of Sep 19, 5:34 PM UTC

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