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U.S. Department of Health and Human Services

Class 2 Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System

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 Class 2 Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw Systemsee related information
Date Initiated by FirmJune 04, 2009
Date PostedAugust 27, 2012
Recall Status1 Terminated 3 on July 16, 2014
Recall NumberZ-2274-2012
Recall Event ID 62564
510(K)NumberK072426 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductApelo 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.
Code Information PN# 70175-001 CAT#2006-41-0000 Lot # 00686 
FEI Number 3003855635
Recalling Firm/
Manufacturer		 Atlas Spine, Inc.
1555 Jupiter Park Dr Ste 4
Jupiter FL 33458-8085
For Additional Information ContactTom Smith
561-741-1108 Ext. 102
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionConsignees were notified by Telephone and visit. All products will be returned, quarantined and then destroyed.
Quantity in Commerce4 pieces
DistributionUSA Distribution to the state of Florida only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NKB
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