Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System. |
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| Recall Number | Z-2274-2012 |
| Classification | Class II |
| Code Info | PN# 70175-001 CAT#2006-41-0000 Lot # 00686 |
| Product Distributed Qty | 4 pieces |
| Reason For Recall | Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery. |
Event Detail
| Event Id | 62564 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Atlas Spine, Inc. |
| City | Jupiter |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-06-04 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | USA Distribution to the state of Florida only. |
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