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 8420.15.020Bone Screw/Vite - Ti6AI4VSelf Tapping/AutofilettanteDia=6.5mmh=25mmSTERILE R2100099
- 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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