SPINEART recalls PERLA TL Lateral Connector Open models with incorrect rod size labeling. Affected units may have wrong size labels, potentially causing improper spinal fixation in pediatric cases.
“SPINEART PERLA TL Lateral Connector Open: Incorrect Rod Size Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62810-spineart-perla-tl-lateral-connector-open-incorrect-rod-size-labeling. Based on FDA recall #Z-1975-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1975-2021%22&limit=1).
SPINEART SA voluntarily recalled PERLA TL Lateral Connector Open devices on April 9, 2021, due to external labeling errors listing incorrect rod sizes, the FDA said. The agency announced the Class II recall via official record Z-1975-2021.
How to tell if you have it
Brand: SPINEART
Product: PERLA TL Lateral Connector Open
Sizes: 15mm, 30mm
Reference Numbers: -TLF-LC OP 15-S, -TLF-LC OP 30-S
Lot Codes: 5-2983, 5-2993
Distribution: U.S. Nationwide in CA, MA, and NC
The hazard
The affected product's external labels list the incorrect rod size due to an external labeling error or mix-up, according to the FDA.
Context
GovInfoNow's records show SPINEART SA has 5 other recalls on record since November 27, 2017. Other recent recalls of similar products include PERLA Cannulated Fenestrated Polyaxial Screw Recall (June 30, 2025), Spineart PERLA TL 25D Screw Recall (March 15, 2024), and SPINEART JULIET Ti Lateral Lumbar Plate Recall (March 16, 2023). Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (February 18, 2026) and BD InLay Optima Ureteral Stent Kit (November 6, 2025).
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).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Massachusetts, North Carolina.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-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.