Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used. |
|---|---|
| Recall Number | Z-0038-2013 |
| Classification | Class II |
| Code Info | All lots except those starting with SY |
| Product Distributed Qty | 247 units |
| Reason For Recall | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
Event Detail
| Event Id | 63157 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Medtronic Sofamor Danek USA Inc |
| City | Memphis |
| State | TN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-30 |
| 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 (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico. |
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