Reported Nov 30, 2016 · Terminated

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed…

Depuy Orthopaedics 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: Depuy Orthopaedics Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

    • ACTIS Flex Reamers SZ 0/1
    • 2/3
    • 4/5
    • 6/7
    • 8/9
    • 10/11
    • 12
    • Product is sold non-sterile
    • these instruments are packed non-sterile
    • within a rigid tube with foam protectors
    • with label and IFU
Lot codes and dates
  • Product Codes
    • 201001210
    • ACTIS FLEX REAMER SZ 0/1
  • GTIN
    • 10603295434818
    • 201001220
    • ACTIS FLEX REAMER SZ 2/3
  • GTIN
    • 10603295434870
    • 201001230
    • ACTIS FLEX REAMER SZ 4/5
  • GTIN
    • 10603295434849
    • 201001240
    • ACTIS FLEX REAMER SZ 6/7
  • GTIN
    • 10603295434856
    • 201001250
    • ACTIS FLEX REAMER SZ 8/9
  • GTIN
    • 10603295434863
    • 201001260
    • ACTIS FLEX REAMER SZ 10/11
  • GTIN
    • 10603295434825
    • 201001270
    • ACTIS FLEX REAMER SZ 12
  • GTIN10603295434832
Amount recalled
137

Where it was sold

Why it was recalled

DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

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 Jun 6, 2017 · Data as of Sep 19, 4:44 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.