FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2651-2010
- Recalling firm
- Gyrus Acmi, Incorporated
- 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
- Status
- Terminated
- Initiated
- 2010-08-06
- Posted
- 2010-09-30
- Terminated
- 2012-01-26
- 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, LITHUANIA, SWEDEN, SWITZERLAND, SAUDI ARABIA, TURKEY, and GREAT BRITAIN
- Lot, serial or model codes
- All lots manufactured from June 1, 2007 through June 7, 2010.
- 510(k) numbers
- ["K041285"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3003790304
- Firm city
- Southborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28