PERLA TL recallZ-1758-2024 · Spineart SA · initiated Mar 15, 2024
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
Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
FDA root cause category: Process design
What the company is doing
On 03/15/2024, the firm called and then emailed one distributor, Spineart USA, Inc.(U.S. Distribution Center) to quarantine products in stock and identify locations of products already distributed. the firm's U.S. Distribution Center sent an "URGENT: MEDICAL DEVICE RECALL" letter on 04/08/2024 via email to customers to inform them that Customers have been instructed as follow: 1. Immediately review your inventory and quarantine concerned products if any. 2. You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to Spineart warehouse SPINEART SLI, ATTN LAURE-ALLISON VERBOUX, 80 RUE DOUGLAS ENGELBART FR-74160 ST JULIEN EN GENEVOIS E-mail: [email protected]
Recall details
- Recall number
- Z-1758-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 15, 2024
- Posted by the FDA
- May 3, 2024
- Recalling firm
- Spineart SA
- Quantity
- 242 systems
- Product code
- NKB
- FDA submissions
- K193396
- Distribution
- U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.
Product description
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model Numbers/Lot-Batch Numbers: TLF-DS 45 25-S 7-4407 TLF-DS 45 25-S 7-6207 TLF-DS 45 30-S 7-4244 TLF-DS 45 30-S 7-6226 TLF-DS 45 35-S 7-4242 TLF-DS 45 35-S 7-5470 TLF-DS 45 35-S 7-6684 TLF-DS 45 40-S 7-6232 TLF-DS 45 45-S 7-5474 TLF-DS 45 45-S 7-6874 TLF-DS 55 30-S 7-4409 TLF-DS 55 30-S 7-4695 TLF-DS 55 30-S 7-4965 TLF-DS 55 35-S 7-4413 TLF-DS 55 35-S 7-6455 TLF-DS 55 40-S 7-4415 TLF-DS 55 40-S 7-4417 TLF-DS 55 45-S 7-4411 TLF-DS 55 45-S 7-5055 TLF-DS 55 45-S 7-6087 TLF-DS 55 45-S 7-6459 TLF-DS 65 35-S 7-4405 TLF-DS 65 35-S 7-6230 TLF-DS 65 35-S 7-6461 TLF-DS 65 35-S 7-6882 TLF-DS 65 40-S 7-4248 TLF-DS 65 40-S 7-4250 TLF-DS 65 40-S 7-5480 TLF-DS 65 40-S 7-6228 TLF-DS 65 40-S 7-6554 TLF-DS 65 40-S 7-6740 TLF-DS 65 45-S 7-4582 TLF-DS 65 45-S 7-5484 TLF-DS 65 45-S 7-5808 TLF-DS 65 45-S 7-6668 TLF-DS 65 45-S 7-6742 TLF-DS 65 45-S 7-7299 TLF-DS 65 50-S 7-5488 TLF-DS 65 50-S 7-9264 UDI-DI for associated Model Numbers: TLF-DS 45 25-S 07640185345799 TLF-DS 45 30-S 07640185345805 TLF-DS 45 35-S 07640185345812 TLF-DS 45 40-S 07640185345829 TLF-DS 45 45-S 07640185345836 TLF-DS 55 30-S 07640185345850 TLF-DS 55 35-S 07640185345867 TLF-DS 55 40-S 07640185345874 TLF-DS 55 45-S 07640185345881 TLF-DS 60 35-S 07640305166082
Devices named in this recall
10 devices in the FDA device registry whose identifier appears in the recall's code information.
- PERLA ® TL TLF-DS 45 25-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 30-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 35-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 40-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 45-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 30-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 35-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 40-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 45-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 60 35-SSpineArt SA · Appliance, Fixation, Spinal Interlaminal1 recall0 reports
Product lines
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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