Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an
FDA device recall Z-1752-2015 · posted 2015-06-11 · Terminated
Recall details
- Recalling firm
- Gyrus Acmi, Incorporated
- Reason for recall
- Potential lack of sterility assurance.
- Action taken
- The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 12,020 boxes
- Distribution
- Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
- Date initiated
- 2015-05-08
- Date posted
- 2015-06-11
- Date terminated
- 2016-05-17
- Location
- Southborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ENERGY POWER SYSTEM (EPS) (K123429) | Gyrus Acmi, Inc. | 2013-04-05 |