CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report

Perla ¿ Tl Mis Cannulated Fenestrated Polyaxial Screw recalled

Spineart is recalling Perla ¿ Tl Mis Cannulated Fenestrated Polyaxial Screw, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Lot number 8-4266 GTIN 07640305160493

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2280-2025
FDA event ID: 97248
Recalling firm: Spineart, Plan-Les-Ouates, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2025
FDA classified: 8 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

30 Jun 2025	Recall initiated by company
8 Aug 2025	Classified by FDA	+39 days
20 Aug 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Product as listed by the FDA

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW

Where it was distributed

US Nationwide distribution in the states of Florida , Kentucky, California.

Nationwide California Florida Kentucky

Questions about this recall

Why was it recalled?

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Which lots are affected?

Lot Code: Lot number 8-4266 GTIN 07640305160493

Where was it sold?

US Nationwide distribution in the states of Florida , Kentucky, California.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97248

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025	CLASS II	Perla ¿ Tl Mis Cannulated Fenestrated Polyaxial Screw recalled	Spineart	Labeling Errors	Nationwide

More recalls from Spineart

All 13

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Device	CLASS II	Perla ¿ Tl Mis Cannulated Fenestrated Polyaxial Screw recalled	Spineart	Labeling Errors	Nationwide
15 May 2024Device	CLASS II	Perla Tl 25d Screw recalled by Spineart	Spineart	Other	Nationwide
3 May 2023Device	CLASS II	Juliet Ti LL, Lateral Lumbar Ti-life Plate Small recalled by Spineart	Spineart	Other	Nationwide
7 Jul 2021Device	CLASS II	Perla TL Lateral Connector Open recalled by Spineart	Spineart	Labeling Errors	Nationwide
4 Dec 2019Device	CLASS III	Intersomatic Juliet Ti OL cage recalled by Spineart	Spineart	Device Malfunction	CA

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide