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Terminated

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

FDA Recall Z-2651-2010 · Posted 2010-09-30

Recalling FirmGyrus Acmi, Incorporated
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-08-06
Date Terminated2012-01-26
Product Quantity4244 units

Reason for Recall

Lack of sterility assurance due to compromised package seals.

Firm 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.

Root Cause

Packaging

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)Gyrus Medical , Ltd. · 2004-09-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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