Device product
GEM Coupler Forceps, GEM4183C, packaged individually.
Z-0680-2019
Product summary
- Event
- Event 81581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 123 devices
- Official record key
device-enforcement:Z-0680-2019
Official wording
Reason: Potential presence of rust on Coupler Forceps (GEM4183C).
Code information: Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Distribution pattern: Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia
Derived failure modes
-
Unknown
Potential presence of rust on Coupler Forceps (GEM4183C).