SAFE ORTHOPAEDICS LLC: Medical Device Recall in 2022 - (Recall #: Z-1572-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 3, 2022

Date Posted: August 31, 2022

Recall Number: Z-1572-2022

Event ID: 90542

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.

Status: Completed

Product Quantity: 8 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated