Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine. |
|---|---|
| Recall Number | Z-0921-2013 |
| Classification | Class II |
| Code Info | Part Number: GCSF37512 and Lot Number: 0243 |
| Product Distributed Qty | 9 cervical screws |
| Reason For Recall | Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery. |
Event Detail
| Event Id | 64421 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Genesys Orthopedic Systems, LLC |
| City | Austin |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA Nationwide Distribution including the states of: CA and TX. |
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