Recalls / —
—#154570
Product
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- FDA product code
- GDW — Staple, Implantable
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K111111
- Affected lot / code info
- N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
Why it was recalled
There is a risk that the pinion gear in the device could fail under extreme use cases.
Root cause (FDA determination)
Process control
Action the firm took
Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
Recalling firm
- Firm
- Ethicon Endo-Surgery Inc
- Address
- 4545 Creek Rd, Blue Ash, Ohio 45242-2803
Distribution
- Distribution pattern
- Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Timeline
- Recall initiated
- 2017-03-31
- Terminated
- 2018-05-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.