4 results
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52ms
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Sources: EU EUDAMED, US FDA
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Recall
Completed
·SAFE ORTHOPAEDICS LLC·Product code NKB·June 3, 2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Enforcement
Class II
·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices