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Recall Observatory FDA recall evidence

Device 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.

Z-2224-2012

July 27, 2012

Class II

Product summary

Firm
Biomet U.K., Ltd.
Event
Event 62745
Status
Terminated
Classification
Class II
Quantity
119 units
Official record key
device-enforcement:Z-2224-2012

Official wording

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

Code information: Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.

Distribution pattern: Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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