Enforcement Report - Week of November 14, 2012
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Event Detail
| Event ID | 63412 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Ormco/Sybronendo |
| City | Glendora |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-12-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. | Part Numbers 601-0007 and 601-0010, all lots | Class II | The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130°C. The correct sterilization temperature should be listed as 132°C and/or 270°F. | 4,543 | Z-0205-2013 |
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