Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an incorrectly labeled surgical screw could be selected in error, and no injuries are reported.
Plain-English summary
The PERLA TL MIS Cannulated Fenestrated Polyaxial Screw, model and catalog number MPF-PS 55 45-S, is being recalled. The affected product carries lot number 8-4266 and GTIN 07640305160493. The recall record lists 0 units, with distribution in Florida, Kentucky and California.
The recall was issued because the cannulated fenestrated polyaxial screws may be incorrectly labeled. The FDA classified the action as Class II.
Hospitals and surgical centres holding this catalog number should check the lot number above, quarantine affected stock and follow the manufacturer's instructions for return.
The recalled product
- Product
- Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
- Manufacturer
- SPINEART SA
- Hazard
- mislabeling
- surgical-screw
- class-ii
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 8-4266 GTIN 07640305160493
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22