Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening. |
|---|---|
| Recall Number | Z-0903-2013 |
| Classification | Class II |
| Code Info | Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090. |
| Product Distributed Qty | 2 |
| Reason For Recall | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
Event Detail
| Event Id | 64195 |
|---|---|
| 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 | Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT. |
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