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U.S. Department of Health and Human Services

Class 2 Device Recall SwiftLock Anchor, Model 1192

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  Class 2 Device Recall SwiftLock Anchor, Model 1192 see related information
Date Initiated by Firm February 22, 2010
Date Posted April 21, 2010
Recall Status1 Terminated 3 on July 22, 2010
Recall Number Z-1425-2010
Recall Event ID 55142
510(K)Number K092371  
Product Classification stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
Product Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company.

Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
Code Information All lots.
Recalling Firm/
Manufacturer		 Advanced Neuromodulation Systems, Inc
6901 Preston Rd
Plano TX 75024-2508
Manufacturer Reason
for Recall		 Directions For Use of product incorrectly stated lead compatibility information.
FDA Determined
Cause 2		 Other
Action An "Urgent Medical Device Correction" letter dated March 8, 2010, was sent to the customers (note: Firm verbally informed consignees on February 22, 2010.). The letter describes the product, problem and action to be taken by the firm -St. Jude Medical. The firm's Sales Representatives will contact the customers to update any DFUs in their possession. If you need additional copies of the insert or more information and if you have any questions or concerns, please contact your St. Jude Medical Sales Representative at 1-651-490-4470.
Quantity in Commerce 1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives)
Distribution Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.
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.
510(K) Database 510(K)s with Product Code = GZB and Original Applicant = ADVANCED NEUROMODULATION SYSTEMS
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