Z-1572-2022Class II

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

Name: Z-1572-2022 SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740
Creator: Safe Orthopaedics Llc
Published: 2022-06-03
License: https://open.fda.gov/license/

Safe Orthopaedics / initiated 2022-06-03 / Completed / root cause: labeling and UDI

FDA source

SAFE ORTHOPAEDICS LLC began a recall of SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740 on 2022-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1572-2022
Classification: Class II
Status: Completed
Initiated: 2022-06-03
Posted: 2022-08-24
Recalling firm: Safe Orthopaedics
Product: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.
Quantity in commerce: 8 devices
Distribution: Distribution was made to MD. There was no government/military distribution.
Product codes and lots: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1572-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1572-2022	Class II	Completed	Voluntary: Firm initiated	2022-08-31	2022-08-24

Product code NKB

K201648Class IISterispine™ PSSafe Orthopaedics / cleared 2020-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)