Cannulated Fenestrated Polyaxial Screws Recalled for Incorrect Labeling
SPINEART SA is recalling certain Cannulated Fenestrated Polyaxial Screws (PERLA TL MIS) due to incorrect labeling. The affected devices were distributed in Florida, Kentucky, and California.
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: This is a Class II FDA medical device recall for labeling errors on a surgical implant used in spinal procedures. Although no injuries have been reported, incorrect labeling on surgical devices poses a risk of patient harm through improper device selection or placement. Per the severity rubric, this qualifies as High under the criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
SPINEART SA is recalling certain Cannulated Fenestrated Polyaxial Screws (model MPF-PS 55 45-S, branded as PERLA TL MIS, Lot Code 8-4266) because they may be incorrectly labeled. Incorrect labeling on surgical implants could affect device selection, placement accuracy, or surgical technique during spinal procedures.
The recalled screws were distributed nationwide in Florida, Kentucky, and California. Affected individuals may be patients who have received or were scheduled to receive this device as part of spinal surgery.
If you have received this device, contact your surgeon or healthcare provider immediately. Do not use any devices from the recalled lot. Report any adverse events related to this device to the FDA MedWatch program at 1-888-SAFUSDA (1-888-723-3784) or online at fda.gov/medwatch.
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
- 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 8-4266 GTIN 07640305160493
Distribution
Distributed nationwide across the United States.
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