Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S
Summary
The FDA issued a Class II for Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW by SPINEART SA. Reason: Cannulated fenestrated polyaxial screws may be incorrectly labeled.
Details
Source
Device Recall
External ID
Z-2279-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: Lot number 8-4528 GTIN 07640305160561
Quantity Affected: 16 units
Reason for Recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Distribution
US Nationwide distribution in the states of Florida , Kentucky, California.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-30
Company
Plan-Les-Ouates, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SPINEART SA has 14 FDA actions in our database, including 5 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SPINEART SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SPINEART SA have FDA actions?
SPINEART SA has 14 FDA actions in our database, including 5 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2279-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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