Z-0159-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- June 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151 units
Product Description
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Reason for Recall
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.
Code Information
2103525