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
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.
The setscrew may not tighten to the correct torque or become misaligned after insertion. This could compromise the spinal stabilization during surgery, potentially leading to improper fixation of the spine segments.
Patients who received spinal surgery using the recalled PERLA TL 25D screws with model numbers starting with TLF-DS 45-65 series are affected. Surgeons and medical staff using these screws for spinal stabilization are most at risk.
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.
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.
Reach out to Spineart directly for guidance on whether your specific model and lot number are affected.
The setscrew may not tighten to the correct torque or become misaligned after insertion, which could compromise spinal stability during surgery.
Check for model numbers starting with TLF-DS 45-65 series (e.g., TLF-DS 45 25-S) and lot numbers like 7-4407 or 7-6207.
Contact Spineart directly to determine if your specific model and lot number are affected; they will provide guidance on next steps.
We’ve drafted a message you can send Spineart to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2024 — Spineart Spineart Hello, I own a Spineart that is covered by recall Z-1758-2024 from Spineart. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
