Spineart recalls PERLA TL 25D screws with model numbers TLF-DS 45-65 series due to setscrew insertion problems that may cause improper tightening or misalignment.
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
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📍Recalling firmSPINEART SAChemin Du Pre-Fleuri 3 · Plan-Les-Ouates, Switzerland
✎ GovInfoNow plain-language explainer
Spineart is recalling certain PERLA TL 25D spinal screws because they can be difficult to insert setscrews properly. This could lead to the setscrew not being tightened correctly or being misaligned, which might affect spinal stability during surgery. Read more at govinfonow.com/recall/55869-spineart-perla-tl-25d-screw-recall-setscrew-insertion-issues.
“Spineart PERLA TL 25D Screw Recall: Setscrew Insertion Issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55869-spineart-perla-tl-25d-screw-recall-setscrew-insertion-issues. Based on FDA recall #Z-1758-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2024%22&limit=1).
The FDA announced on March 15, 2024, that Spineart is recalling PERLA TL screws due to setscrew insertion difficulties. The agency said the issue may result in the setscrew not being tightened to torque or being positioned askew.
The FDA said the recall addresses difficulties with inserting a setscrew inside the screw head. These issues involve either the setscrew not being tightened to torque or being tightened to torque but positioned askew.
Context
GovInfoNow's records show Spineart has issued five other recalls since November 27, 2017. Other recent recalls of similar products include PERLA Cannulated Fenestrated Polyaxial Screw Recall (June 30, 2025), SPINEART JULIET Ti Lateral Lumbar Plate Recall (March 16, 2023), and SPINEART PERLA TL Lateral Connector Open (April 9, 2021). Other recent recalls of similar products include Tornier Perip Screw Recall (December 19, 2025), Innovasis Anti-Torque Vector Pedicle Screw LS-749 Recall (May 22, 2026), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (February 2, 2026).
How to tell if you have this one
Check for model numbers starting with TLF-DS 45-65 series (e.g., TLF-DS 45 25-S, TLF-DS 55 30-S) and lot numbers like 7-4407 or 7-6207. The product is used in spinal surgery for stabilizing the thoracic, lumbar, and sacral spine.
Brand
Spineart
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Numbers
Identify if your screw has model numbers starting with TLF-DS 45-65 series (e.g., TLF-DS 45 25-S) and associated lot numbers like 7-4407.
Contact Spineart
Reach out to Spineart directly for guidance on whether your specific model and lot number are affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Kentucky.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1758-2024 (March 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1758-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.