Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures. |
|---|---|
| Recall Number | Z-2057-2012 |
| Classification | Class II |
| Code Info | Lot number: 7736703 and part number: 00-1050-4308 |
| Product Distributed Qty | 15 devices |
| Reason For Recall | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. |
Event Detail
| Event Id | 62351 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | OrthoPediatrics Corp |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-14 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia. |
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