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U.S. Department of Health and Human Services

Class 2 Device Recall GYRUS ACMI, dissector PlasmaKnife

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 Class 2 Recall
GYRUS ACMI, dissector PlasmaKnife
see related information
Date Posted September 30, 2010
Recall Status1 Terminated on January 26, 2012
Recall Number Z-2651-2010
Recall Event ID 56304
Premarket Notification
510(K) Number
K041285 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
Code Information All lots manufactured from June 1, 2007 through June 7, 2010.
Recalling Firm/
Manufacturer
Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough, Massachusetts 01772-2118
For Additional Information Contact Terrence E. Sullivan
508-804-2600
Manufacturer Reason
for Recall
Lack of sterility assurance due to compromised package seals.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action The firm initiated their recall to their direct accounts by Priority Mail with delivery confirmation on 08/06/2010. The letter requested return of the product and was extended to the retail level.
Quantity in Commerce 4244 units
Distribution Worldwide In the United States: AL, AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and the District of Columbia. Foreign: UK, TAIWAN, SOUTH KOREA, GERMANY, CANADA, AUSTRALIA, SPAIN, ITALY, ISRAEL, NORWAY, LITHUANIA, SWEDEN, SWITZERLAND, SAUDI ARABIA, TURKEY, and GREAT BRITAIN
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS MEDICAL LTD.
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