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
ZB111101ZBll1201ZB120101ZB120501ZB111102and 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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