Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when prep

FDA device recall Z-2224-2012 · posted 2012-08-17 · Terminated

Recall details

Recalling firm

Biomet U.K., Ltd.

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

Action taken

Biomet sent a "FIELD SAFETY CORRECTIVE ACTION" letter dated July 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Response Form was attached for customers to complete and return. Contact the firm for questions regarding this notice.

Root cause

Device Design

Status

Terminated

Product code

IQO

Quantity affected

119 units

Distribution

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

Date initiated

2012-07-27

Date posted

2012-08-17

Date terminated

2013-02-15

Location

South Wales, Bridgend, United Kingdom