Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. |
|---|---|
| Recall Number | Z-0942-2013 |
| Classification | Class II |
| Code Info | All Lots |
| Product Distributed Qty | 596 |
| Reason For Recall | There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized. |
Event Detail
| Event Id | 64287 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Synthes USA HQ, Inc. |
| City | West Chester |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland. |
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