Z-0680-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 2, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 devices
Product Description
GEM Coupler Forceps, GEM4183C, packaged individually.
Reason for Recall
Potential presence of rust on Coupler Forceps (GEM4183C).
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
Code Information
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850