Reported Aug 26, 2020 · Ongoing

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the…

Smith & Nephew Orthopaedics AG

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 Orthopaedics AG · Schachenallee 29 · Aarau, N/A · N/A

Is this the product you have?

  • POLARSTEM COLLAR Reamer Guide
  • Catalog Number75102205
  • UPC Codes00885556535493 -
  • Product UsageOnce the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide
Lot codes and dates
  • Serial Numbers
    • A56281
    • A57539
    • A58660
    • A600630
    • A61590
    • A62616 & A62689
Amount recalled
528 unit

Where it was sold

Why it was recalled

Multiple lots being recalled due to a product design issue

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

Data as of Sep 19, 5:29 PM UTC

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