AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for end
FDA device recall Z-1814-2017 · posted 2017-03-20 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems LLC
- Reason for recall
- Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
- Action taken
- On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GWG
- Quantity affected
- 21 units distributed in U.S.
- Distribution
- Product was distributed throughout the United States and Canada.
- Date initiated
- 2017-03-07
- Date posted
- 2017-03-20
- Date terminated
- 2018-02-16
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP MINOP SYSTEM (K983365) | Aesculap, Inc. | 1998-12-18 |