FDA Medical Device Recalls (openFDA)
Biomet U.K., Ltd.: 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.
- Recall number
- Z-2224-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-07-27
- Posted
- 2012-08-17
- Terminated
- 2013-02-15
- 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
- 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
- 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.
- Lot, serial or model codes
- Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQO
- Firm FEI
- 3002806535
- Firm city
- South Wales
- Firm state
- Bridgend
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28