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U.S. Department of Health and Human Services

Class 2 Device Recall Dekompressor Percutaneous Discectomy Probe

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  Class 2 Device Recall Dekompressor Percutaneous Discectomy Probe see related information
Date Initiated by Firm November 04, 2013
Date Posted November 01, 2013
Recall Status1 Terminated 3 on April 29, 2014
Recall Number Z-0127-2014
Recall Event ID 66456
510(K)Number K032473  
Product Classification Arthroscope - Product Code HRX
Product Dekompressor Percutaneous Discectomy Probe.

The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
Code Information Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-323-7700
Manufacturer Reason
for Recall		 Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m
FDA Determined
Cause 2		 Device Design
Action On 11/4/13, an URGENT MEDICAL DEVICE Recall Notification was sent to all domestic consignees via mail and foreign by email. An advisory was sent to every physician that uses any of the products listed. Every physician that uses any of these products must print their name and sign below which means you acknowledge that youve received a copy of the attached advisory and that you understand the information regarding the proper usage of the Decompressor. Once the form has been signed by all physicians, the form must be completed and signed by the recall coordinator. Please fax to 866-521-2762 or email to kara.spath@stryker.com.
Quantity in Commerce 20,385 total distributed since 2004
Distribution Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
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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