Reported Oct 31, 2018 · Terminated

Mitek Screw and Washer Depth Gauge, Product Code 219024

DePuy Mitek, Inc., a Johnson & Johnson Co.

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 Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Dr · Raynham, MA · 02767-5199

Is this the product you have?

  • Mitek Screw and Washer Depth Gauge, Product Code 219024
Lot codes and dates
  • UDI10886705005390
  • Lot Numbers
    • 0005178
    • 1103107
    • 0009101
    • 1105132
    • 0009181
    • 1112106
    • 0102157
    • 1201104
    • 0103045
    • 950229
    • 0205355
    • 961232
    • 0207451
    • 970198
    • 0208597
    • 971229
    • 0301615
    • 980585
    • 0302184
    • 9809121
    • 0303337
    • 990765
    • 0311333
    • C000007655
    • 0311389
    • C000012527
    • 0512552
    • C000020182
    • 0605571
    • 1000196842
    • 0612501
    • 1000415749
    • 0707512
    • 1000431580
    • 0710501
    • 1000661713
    • 0801536
    • 1001119996
    • 0809117
    • 1002144
    • 0905130
    • 1006113
    • 0912100
    • 1008120
    • 1000064514
    • 1103103
Amount recalled
401

Where it was sold

Why it was recalled

The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.

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 5, 2020 · Data as of Sep 19, 5:34 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.