FDA Medical devices recall ·
PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model recall
- Recall number
- Z-2279-2025
- Date
- (initiated June 30, 2025)
- Company / brand
- Spineart Sa
Chemin Du Pre-Fleuri 3, Plan-Les-Ouates, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Cannulated fenestrated polyaxial screws may be incorrectly labeled
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot number 8-4528 GTIN 07640305160561
Distribution
US Nationwide distribution in the states of Florida , Kentucky, California.
States: California Florida Kentucky
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2279-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.