FDA recall Z-0160-2022

Product

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

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

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.

Key facts

Status

Terminated

Initiation date

2021-10-01

Report date

2021-10-27

Termination date

2024-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2022