Recall Z-2651-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus Acmi, Incorporated
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
| Date | Sep 30, 2010 (initiated Aug 6, 2010) |
| Status | Terminated |
| Reason | Lack of sterility assurance due to compromised package seals. |
| Root cause | 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 | 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, L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) Gyrus Medical , Ltd., Sep 10, 2004 |