Z-1829-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- April 26, 2018
- Termination Date
- June 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,271 units in total
Product Description
(1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Reason for Recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Distribution Pattern
Worldwide and US Nationwide
Code Information
(1) Lot Number: 0214050554 (2) Lot Numbers: 0214907029,0214991119,0215130754,0215158268