Device product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Z-1572-2022
Product summary
- Event
- Event 90542
- Status
- Completed
- Classification
- Class II
- Quantity
- 8 devices
- Official record key
device-enforcement:Z-1572-2022
Official wording
Reason: 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.
Code information: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
Distribution pattern: Distribution was made to MD. There was no government/military distribution.
Derived failure modes
-
Labeling or packaging
label is incorrect