Enforcement Report - Week of October 10, 2012
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Event Detail
| Event ID | 62773 |
|---|---|
| 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 | 2012-06-18 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). | Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A | Class II | Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment. | 1602 | Z-0001-2013 |
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