Cannulated Fenestrated Polyaxial Screws Recalled Due to Incorrect Labeling
SPINEART SA is recalling PERLA TL MIS Cannulated Fenestrated Polyaxial Screws (Model MPF-PS 65 40-S, Lot 8-4528) due to incorrect labeling. Affected units were distributed nationwide in Florida, Kentucky, and California.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall for a labeling error with no reported illnesses, injuries, or hospitalizations. Per the rubric, minor labeling errors are classified as Moderate (Score 2).
Plain-English summary
SPINEART SA is recalling 16 units of PERLA TL MIS Cannulated Fenestrated Polyaxial Screws (Model MPF-PS 65 40-S, Lot number 8-4528) due to incorrect labeling. The affected devices were distributed nationwide in Florida, Kentucky, and California.
These cannulated fenestrated polyaxial screws are medical devices used in spinal surgical procedures. The recalled units may have incorrect labeling, which could affect device identification and selection during surgical use.
Patients or healthcare providers who have received, purchased, or used the recalled device should contact SPINEART SA or their healthcare provider for further guidance. The manufacturer recommends verifying the device lot number against recall information before use.
The recalled product
- 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
- Manufacturer
- SPINEART SA
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot number 8-4528 GTIN 07640305160561
Distribution
Distributed nationwide across the United States.
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