Z-2265-2013 Class II Terminated
FDA device recall Z-2265-2013 was initiated by Endoplus, Inc. on July 15, 2013 and is designated Class II. Reason for recall: Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. The recall status is terminated (terminated February 8, 2016). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2013
- Initiation Date
- July 15, 2013
- Termination Date
- February 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Reason for Recall
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Distribution Pattern
Distributed in the states of FL, TX, and VA.
Code Information
Item: 345VA; Lot Number: F3