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U.S. Department of Health and Human Services

Class 2 Device Recall T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System

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  Class 2 Device Recall T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System see related information
Date Initiated by Firm August 12, 2013
Date Posted September 14, 2013
Recall Status1 Terminated 3 on December 27, 2013
Recall Number Z-2200-2013
Recall Event ID 66010
Product Classification Screwdriver - Product Code HXX
Product T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA,

Product Usage:
The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
Code Information RS12K008
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall
One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.
Quantity in Commerce 9 units
Distribution USA Nationwide Distribution in the state of GA, AK, WA, and CA.
Total Product Life Cycle TPLC 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.
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