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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
Part of a larger recall action
This product is one of 2 recalled by SPINEART SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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