Limacorporate S.p.A recalls REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01

Recalled October 27, 2021 · FDA recall Z-0160-2022 · 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. · FDA Class II

Units

200 units

Sold at

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.

Description

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

Product

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

Manufacturer(s)

Limacorporate S.p.A

Made in

Italy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →