Limacorporate S.p.A Recall 88812
Description: REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Limacorporate S.p.A Recall 88812 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0159-2022 |
| Event ID | 88812 |
| Event Description | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 151 units |
| Recall 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. |
| Device Classification | 20211027 |
| Device Code Info | 2103525 |
| Center Classification Date | 20211021 |
| Recall Initiation Date | 20211001 |
| Recalling Firm | Limacorporate S.p.A |
| Initial Notification | |
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