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[Recalled] 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. — A drafting error during an unrelated design change has

recall fda device united-kingdom

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductOxford 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.
Brand / manufacturerBiomet U.K., Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2224-2012
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date27 July 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Biomet U.K., Ltd.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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