Reported Oct 27, 2021 · Terminated

REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI:…

Limacorporate S.p.A

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A

Is this the product you have?

    • REF 8420.15.020
    • Bone Screw/Vite - Ti6AI4V
    • Self Tapping/Autofilettante
    • Dia=6.5mm
    • h=25mm
    • STERILE R
    • 2100099
  • UDI(01)08033390018852
Lot codes and dates
  • 2103525
Amount recalled
151 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 27, 2024 · Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.