Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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 |
| Classification | Class II |
| Code Info | Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201. |
| Product Distributed Qty | 119 units |
| 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 |
Event Detail
| Event Id | 62745 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Biomet U.K., Ltd. |
| City | Bridgend, South Wales |
| State | Country | GB |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK. |
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