LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X RE
FDA device recall Z-2688-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- LINA Medical ApS
- Reason for recall
- Potential for the LiNA Loop to break during operating procedure.
- Action taken
- Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- KNF
- Quantity affected
- 200 pieces
- Distribution
- GA, MN, PA, WA, TN, MA, IN, Ontario Canada
- Date initiated
- 2009-12-01
- Date posted
- 2011-06-28
- Date terminated
- 2012-02-23
- Location
- Glostrup, Denmark
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (K070315) | Lina Medical Aps | 2007-10-30 |