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U.S. Department of Health and Human Services

Class 2 Device Recall Poly Stim II Nerve Stimulator for Stryker Pain Pump

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 Class 2 Device Recall Poly Stim II Nerve Stimulator for Stryker Pain Pumpsee related information
Date Initiated by FirmFebruary 01, 2010
Date PostedSeptember 03, 2010
Recall Status1 Terminated 3 on March 28, 2011
Recall NumberZ-2360-2010
Recall Event ID 54625
510(K)NumberK990323 
Product Classification Stimulator, nerve, battery-powered - Product Code BXN
ProductPoly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Code Information 0507702223, 0524301373 and 0603705603. 
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information ContactAngela Regainis
269-323-7700
Manufacturer Reason
for Recall		Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.
FDA Determined
Cause 2		Process control
ActionStryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354
Quantity in Commerce18,826 all products
DistributionNationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.
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 = BXN
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