Z-2224-2012Class II

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

Name: Z-2224-2012 Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension...
Creator: Biomet U.K., Ltd.
Published: 2012-07-27
License: https://open.fda.gov/license/

Biomet U.K., Ltd. / initiated 2012-07-27 / Terminated / root cause: design

FDA source

Biomet U.K., Ltd. began a recall of 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... on 2012-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2224-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-08-17
Terminated: 2013-02-15
Recalling firm: Biomet U.K., Ltd.
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.
Product code: IQO Device, Prosthesis Alignment
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2224-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2224-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-17

Product code IQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)