Home / Recalls / SAFE ORTHOPAEDICS LLC / Z-1572-2022

Z-1572-2022 Class II

Recalled by SAFE ORTHOPAEDICS LLC — Chicago, IL

Recall Details

Product Type: Devices
Report Date: August 31, 2022
Initiation Date: June 3, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 devices

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.

Distribution Pattern

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

Code Information

KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.