FDA-Device2021-10-27Class II
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Limacorporate S.p.A
Hazard
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Sold states
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.
Affected count
200 units
Manufactured in
Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy
Products
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief