Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- March 31, 2017
- Terminated
- May 3, 2018
- Recall Number
- Z-2174-2017
- Quantity
- 792 units
- Firm Location
- Blue Ash, OH
Reason for Recall
There is a risk that the pinion gear in the device could fail under extreme use cases.
Distribution
Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Lot / Code Info
N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
Root Cause
Process control
Action Taken
Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
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