|
Class 2 Device Recall GYRUS ACMI, dissector PlasmaKnife |
|
Date Initiated by Firm |
August 06, 2010 |
Date Posted |
September 30, 2010 |
Recall Status1 |
Terminated 3 on January 26, 2012 |
Recall Number |
Z-2651-2010 |
Recall Event ID |
56304 |
510(K)Number |
K041285
|
Product Classification |
Electrosurgical cutting and coagulation device - 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 MA 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 |
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 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 = GEI and Original Applicant = GYRUS MEDICAL LTD.
|
|
|
|