FDAFDA · Food and drugs·Recall number Z-2224-2012
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.
Published August 29, 2012 · Recall initiated: July 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet U.K., Ltd.
- Distributor
- Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
- Lot
- Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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