Recall Z-2274-2012 ยท NKB Thoracolumbosacral Pedicle Screw System
Atlas Spine, Inc.
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
| Date | Aug 27, 2012 (initiated Jun 4, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Consignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed. |
| Quantity | 4 pieces |
| Distribution | USA Distribution to the state of Florida only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, LLC, Oct 19, 2007 |