FDA-Device2022-08-31Class II
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
SAFE ORTHOPAEDICS LLC
Hazard
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
Sold states
Distribution was made to MD. There was no government/military distribution.
Affected count
8 devices
Manufactured in
700 W Irving Park Rd, Chicago, IL, United States
Products
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2022Don't want to check this manually?
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