Recall Z-2224-2012— Biomet U.K., Ltd.
Class II · Terminated
Class II FDA medical device recall by Biomet U.K., Ltd., initiated 2012-07-27, terminated 2013-02-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Biomet U.K., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-27
- Terminated
- 2013-02-15
- Firm location
- Bridgend, South Wales, N/A, United Kingdom
Product description
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.
Reason for recall
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
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