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U.S. Department of Health and Human Services

Class 2 Device Recall Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407265,

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  Class 2 Device Recall Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407265, see related information
Date Initiated by Firm February 03, 2011
Date Posted March 28, 2011
Recall Status1 Terminated 3 on June 01, 2011
Recall Number Z-1829-2011
Recall Event ID 57899
510(K)Number K032473  
Product Classification Arthroscope - Product Code HRX
Product Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI.
The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
Code Information Lot: 10214012.
Recalling Firm/
Manufacturer		 Stryker Instruments Division of Stryker Corporation
4100 East Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact K. Kelly Smith
269-323-7700
Manufacturer Reason
for Recall		 The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.
FDA Determined
Cause 2		 Other
Action Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.
Quantity in Commerce 44 units both products
Distribution Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.
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 = HRX and Original Applicant = STRYKER INSTRUMENTS
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