GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI
FDA device recall Z-2651-2010 · posted 2010-09-30 · Terminated
Recall details
- Recalling firm
- Gyrus Acmi, Incorporated
- Reason for recall
- Lack of sterility assurance due to compromised package seals.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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 Colum
- Date initiated
- 2010-08-06
- Date posted
- 2010-09-30
- Date terminated
- 2012-01-26
- Location
- Southborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) (K041285) | Gyrus Medical , Ltd. | 2004-09-10 |