FDA recall Z-1572-2022

Product

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

Reason for recall

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.

Distribution

Distribution was made to MD. There was no government/military distribution.

Key facts

Status

Completed

Initiation date

2022-06-03

Report date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2022