Reported Apr 26, 2017 · Terminated

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is…

Smith & Nephew, 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: Smith & Nephew, Inc. · 130 & 120 Forbes Blvd · Mansfield, MA · 02048

Is this the product you have?

  • Smith & Nephew ACUFEX TRUNAV
  • Retrograde Drill 9MM Product Number72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Lot codes and dates
  • Batch Numbers
    • F86213
    • F86216
    • G04654
    • G04655
    • G04656
    • G10376 G10377
    • G11224
    • G11226
    • G11237
    • G11238
    • G15935
    • G15936
    • G15937
    • G18822
    • G18823
    • G18824
    • G18826
    • G18837
    • G18838
    • G18840
    • G18841
    • G30215
    • G30216
    • G30247
    • G30248
    • G30256
    • G32169
    • G32173
    • G32174 G32175
    • G32176
    • G32177
Amount recalled
N/A

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

  • Nationwide
  • DE

Why it was recalled

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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 Jul 10, 2018 · Data as of Sep 19, 6:05 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.