Reported May 11, 2016 · Terminated

MAKOplasty Hip Array Kit Laminate 150230

Mako Surgical Corporation

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: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Plantation, FL · 33317-7424

Is this the product you have?

  • MAKOplasty Hip Array Kit Laminate 150230
Lot codes and dates
  • Catalog No. 210540
  • Lot Code150324
Amount recalled
10 units.

Where it was sold

Why it was recalled

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

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 25, 2016 · Data as of Sep 19, 4:46 PM UTC

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