LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division.
This recall has been terminated (originally issued June 28, 2011).
- Recall Initiated
- December 1, 2009
- Posted
- June 28, 2011
- Terminated
- February 23, 2012
- Recall Number
- Z-2689-2011
- Quantity
- 570 pieces
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the LiNA Loop to break during operating procedure.
Distribution
GA, MN, PA, WA, TN, MA, IN, Ontario Canada
Lot / Code Info
Batch 9375, 9395, 9323, 8292, 8393, and 9231
Root Cause
Labeling design
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.