Biomet U.K., Ltd.: Medical Device Recall in 2012 - (Recall #: Z-2224-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 27, 2012

Date Posted: August 29, 2012

Recall Number: Z-2224-2012

Event ID: 62745

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

Status: Terminated

Product Quantity: 119 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated