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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft,

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 Class 2 Device Recall DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft,see related information
Date Initiated by FirmFebruary 11, 2009
Date PostedAugust 14, 2009
Recall Status1 Terminated 3 on July 09, 2015
Recall NumberZ-1670-2009
Recall Event ID 51138
510(K)NumberK070300 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductDePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Code Information Product Code: 2894-10-300; Lot Number: 1208NT.
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information ContactMatthew King
508-828-3769
Manufacturer Reason
for Recall		Tip of Driver may break during use
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
Quantity in Commerce117 units
DistributionNationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
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 = KWP
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