Recall Z-0159-2022— Limacorporate S.p.A
Class II · Terminated
Class II FDA medical device recall by Limacorporate S.p.A, initiated 2021-10-01, terminated 2024-06-27. It names one FDA 510(k) clearance: K172456. Product: REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852. Reason: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included..
- Recalling firm
- Limacorporate S.p.A
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-01
- Terminated
- 2024-06-27
- Firm location
- San Daniele Del Friuli, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Reason for recall
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Data sourced from openFDA. This site is unofficial and independent of the FDA.