FDA Device recall Z-2224-2012
Oxford Gap Gauge SML 3/4mm
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Oxford Gap Gauge SML 3/4mm by Biomet U K, citing 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 acc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2224-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-27 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet U K |
| Distribution | IN, SD, TX |
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.
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
Identifiers
| code_info | Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2012%22
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