Device product
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Z-0159-2022
Product summary
- Event
- Event 88812
- Status
- Terminated
- Classification
- Class II
- Quantity
- 151 units
- Official record key
device-enforcement:Z-0159-2022
Official wording
Reason: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Code information: 2103525
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.
Derived failure modes
-
Unknown
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.