PERLA TL MIS recallZ-2279-2025 · Spineart SA · initiated Jun 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spineart SA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cannulated fenestrated polyaxial screws may be incorrectly labeled
FDA root cause category: Labeling Change Control
What the company is doing
On July 4, 2025, Spineart SA, issued a Urgent: Medical Device Recall Notification to affected consignees via E-Mail. On July 10, 2025, Spineart SA issued a revised notification to provide additional information. On July 16,2025, Spineart expanded the recall to include an additional product and lot. Spineart SA ask consignees to take the following steps: (1) Please acknowledge receipt of this letter by emailing to [email protected] (2) Please discontinue use and return any product on hand that is listed in the Product and Distribution Information section of this letter to: Spineart U.S.A. 23332 Mill Creek Drive Suite 150 Laguna Hills, CA. 92653 (3) You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. (4) Surgeons/physicians should closely monitor patients that have been implanted with these potential non-conforming screws.
Recall details
- Recall number
- Z-2279-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2025
- Posted by the FDA
- Aug 8, 2025
- Recalling firm
- Spineart SA
- Quantity
- 16 units
- Product code
- NKB
- FDA submissions
- K203506
- Distribution
- US Nationwide distribution in the states of Florida , Kentucky, California.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: Lot number 8-4528 GTIN 07640305160561
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PERLA ® TL MIS MPF-PS 65 40-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97248).
- Z-2280-2025 · Open, ClassifiedBrand 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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