Oxford Gap Gauge SML 3/4mm — Class II medical device recall Z-2224-2012
Terminated recall by Biomet U.K., Ltd., reported 2012-08-29, distributed in IN, SD, TX. A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD
| Recall number | Z-2224-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet U.K., Ltd., Bridgend, South Wales, N/A, United Kingdom |
| Recall initiated | 2012-07-27 |
| Classified | 2012-08-17 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-02-15 |
| Distributed | IN, SD, TX |
| Countries outside the US | AT, CN, GB, JP, NL, SE, TR |
| Quantity | 119 units |
| Model numbers | 32-422801 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2224-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.