Recall Z-2174-2017
Ethicon Endo-Surgery Inc · initiated March 31, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Codes / lots: N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
Reason for recall
There is a risk that the pinion gear in the device could fail under extreme use cases.
FDA-determined cause: Process control
Action taken
Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
Details
- Recall number
- Z-2174-2017
- Initiated
- March 31, 2017
- Terminated
- May 3, 2018
- Product code
- GDW – Staple, Implantable
- Quantity
- 792 units
- Distribution
- Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
- Recalling firm
- Ethicon Endo-Surgery Inc, Blue Ash, OH