Reported Aug 29, 2012 · Terminated

Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when…

Biomet U.K., Ltd.

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: Biomet U.K., Ltd. · Waterton Industrial Estate · Bridgend, South Wales, N/A · N/A

Is this the product you have?

  • Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
Lot codes and dates
  • Catalog Number32-422801
  • and Lot Number Identification
    • ZB111101
    • ZBll1201
    • ZB120101
    • ZB120501
    • ZB111102
    • and ZB120201
Amount recalled
119 units

Where it was sold

Why it was recalled

A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension

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 Feb 15, 2013 · Data as of Sep 19, 6:10 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.