Drug recall
Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps…
FDA recall event 62745 · Class II · Biomet U.K., Ltd.
Key facts
| Event ID | 62745 |
|---|---|
| Recall numbers | Z-2224-2012 |
| Recalling firm | Biomet U.K., Ltd. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 27, 2012 |
| Report date | Aug 29, 2012 |
| Termination date | Feb 15, 2013 |
| City | Bridgend, South Wales |
| Country | United Kingdom |
| FEI number | 3002806535 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: