Recall Z-1572-2022— SAFE ORTHOPAEDICS LLC

Name: FDA recall Z-1572-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-03

Class II · Completed

Class II FDA medical device recall by SAFE ORTHOPAEDICS LLC, initiated 2022-06-03. It names one FDA 510(k) clearance: K201648. Product: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.. 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..

Recalling firm: SAFE ORTHOPAEDICS LLC
Classification: Class II
Status: Completed
Initiated: 2022-06-03
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K201648 — Sterispine PSSafe Orthopaedics·cleared 2020-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.