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U.S. Department of Health and Human Services

Class 2 Device Recall STRYKERArthroscopic Blade

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  Class 2 Device Recall STRYKERArthroscopic Blade see related information
Date Initiated by Firm January 26, 2009
Date Posted February 03, 2012
Recall Status1 Terminated 3 on March 09, 2012
Recall Number Z-0956-2012
Recall Event ID 58937
510(K)Number K012635  K012605  
Product Classification Arthroscope - Product Code HRX
Product ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style - Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 203562***Expiration Date: 01/2012.

Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Code Information Lot number: 203562
Recalling Firm/
Ascent Healthcare Solutions
10232 S 51st St
Phoenix AZ 85044-5205
For Additional Information Contact Moira Barton-Varty
Manufacturer Reason
for Recall
On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
FDA Determined
Cause 2
Packaging process control
Action Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 for questions regarding this recall.
Quantity in Commerce 400 devices
Distribution Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada.
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 = ALLIANCE MEDICAL CORP.