Z-2279-2025Class II

Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65...

Name: Z-2279-2025 Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65...
Creator: Spineart Sa
Published: 2025-06-30
License: https://open.fda.gov/license/

Spineart SA / initiated 2025-06-30 / Open, Classified / root cause: labeling and UDI

FDA source

SPINEART SA began a recall of Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product... on 2025-06-30. FDA classified it as Class II and gives the reason as "Cannulated fenestrated polyaxial screws may be incorrectly labeled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2279-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-30
Posted: 2025-08-08
Recalling firm: Spineart SA
Product: Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On July 4, 2025, Spineart SA, issued a Urgent: Medical Device Recall Notification to affected consignees via E-Mail. On July 10, 2025, Spineart SA issued a revised notification to provide additional information. On July 16,2025, Spineart expanded the recall to include an additional product and lot. Spineart SA ask consignees to take the following steps: (1) Please acknowledge receipt of this letter by emailing to [email protected] (2) Please discontinue use and return any product on hand that is listed in the Product and Distribution Information section of this letter to: Spineart U.S.A. 23332 Mill Creek Drive Suite 150 Laguna Hills, CA. 92653 (3) You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. (4) Surgeons/physicians should closely monitor patients that have been implanted with these potential non-conforming screws.
Quantity in commerce: 16 units
Distribution: US Nationwide distribution in the states of Florida , Kentucky, California.
Product codes and lots: Lot Code: Lot number 8-4528 GTIN 07640305160561

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2279-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2279-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2280-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08

Product code NKB

K203506Class IIPERLA® TL posterior osteosynthesis systemSpineart / cleared 2021-01-15

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)