Reported Aug 20, 2025 · Ongoing
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S…
Spineart Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SPINEART SA · Chemin Du Pre-Fleuri 3 · Plan-Les-Ouates, N/A · N/A
Is this the product you have?
- Brand NamePERLA ¿
- TL MIS Product NameCANNULATED FENESTRATED
- POLYAXIAL SCREW Model/Catalog NumberMPF-PS 65 40-S
- Software VersionNot
- Applicable Product DescriptionCANNULATED
- FENESTRATED POLYAXIAL SCREW ComponentNo
- Lot codes and dates
- Lot CodeLot number 8-4528 GTIN 07640305160561
- Amount recalled
- 16 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Cannulated fenestrated polyaxial screws may be incorrectly labeled
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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