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

Agency Publication Date: October 21, 2021

Affected Products

Product: REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

2103525

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

2103825

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88812

Status: Resolved

Manufacturer: Limacorporate S.p.A

Manufactured In: Italy

Units Affected: 2 products (151 units; 200 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Medium RiskFDA Device