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Biomet U.K., Ltd. recalls Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when p
Recalled August 29, 2012 · FDA recall Z-2224-2012 · Biomet U.K
Hazard
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 · FDA Class II
Units
119 units
Sold at
Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
Description
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
Product
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.
Manufacturer(s)
Biomet U.K., Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →