SPINEART PERLA TL Lateral Connector Open: Incorrect Rod Size Labeling Risk

Take action

Contact the company & request your remedy

Recalling firmSPINEART SAChemin Du Pre-Fleuri 3, N/A · Plan-Les-Ouates, N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

SPINEART is recalling two specific models of pediatric spinal connectors due to external labels listing the wrong rod size. This could lead to improper spinal fixation if used in children.

Why it’s dangerous

The external labels on these connectors incorrectly list the rod size. If used in pediatric spinal surgery without verifying the correct size, it could lead to improper fixation. This is a labeling error, not a defect in the product itself.

Who’s affected

Pediatric spinal surgery patients using the PERLA TL Lateral Connector Open models with incorrect rod size labels. Surgeons and medical staff handling these specific models are most at risk.

How to tell if you have this one

Check for the model names: PERLA TL Lateral Connector Open, 15mm or 30mm. Look for the reference numbers: TLF-LC OP 15-S (5-2983) or TLF-LC OP 30-S (5-2993).

Brand
SPINEART
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Label
Verify the rod size listed on the external label matches the model (15mm or 30mm).

✎ GovInfoNow

Questions people ask

Why is this a recall?

The external labels list the incorrect rod size, which could lead to improper spinal fixation in pediatric cases.

What models are affected?

PERLA TL Lateral Connector Open, 15mm (reference number TLF-LC OP 15-S / 5-2983) and 30mm (reference number TLF-LC OP 30-S / 5-2993).

Do I need to stop using these products?

No, but you should check the label to ensure the correct rod size is listed before use.

Take action

Contact SPINEART

We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1975-2021 — SPINEART SPINEART

Hello,

I own a SPINEART that is covered by recall Z-1975-2021 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

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-1975-2021 (April 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1975-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

SPINEART SA recalls PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle

Lower-risk recall