ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/P
FDA device recall Z-1433-06 · posted 2006-08-24 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- Reason for recall
- Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
- Action taken
- On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 5205 units
- Distribution
- Worldwide
- Date initiated
- 2006-03-27
- Date posted
- 2006-08-24
- Date terminated
- 2012-04-27
- Location
- Utica, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS (K924283) | Microsurge, Inc. | 1993-04-07 |