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SAFE ORTHOPAEDICS LLC recalls SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Recalled August 31, 2022 · FDA recall Z-1572-2022 · SAFE ORTHOPAEDICS
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. · FDA Class II
Units
8 devices
Sold at
Distribution was made to MD. There was no government/military distribution.
Description
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.
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Manufacturer(s)
SAFE ORTHOPAEDICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →