PERLA TL MIS Screw (SPINEART) – Incorrect Labeling (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland
Lot Codes / Batch Numbers
Lot Code: Lot number 8-4528 GTIN 07640305160561
Products Sold
Lot Code: Lot number 8-4528 GTIN 07640305160561
SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland is recalling Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Numbe due to Cannulated fenestrated polyaxial screws may be incorrectly labeled. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Recommended Action
Per FDA guidance
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 orders@spineart.us (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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026