CLASS II Device recall · Reported 28 Dec 2022 · FDA Enforcement Report

Vader Pedicle System Torque Wrench, Hudson Coupling, 12 Nm recalled

Icotec Ag is recalling Vader Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, distributed nationwide in the US. The recall was initiated on 3 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

Quantity recalled6 devices

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-0728-2023
FDA event ID: 91174
Recalling firm: Icotec Ag, Altstatten Sg
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2022
FDA classified: 19 Dec 2022
Reported: 28 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Spinal Implants

Timeline

3 Nov 2022	Recall initiated by company
19 Dec 2022	Classified by FDA	+46 days
28 Dec 2022	Published in enforcement report	+9 days

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

Reason for recall

During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Where it was distributed

US Nationwide distribution in the state of GA.

Nationwide Georgia

Questions about this recall

Is Vader Pedicle System Torque Wrench, Hudson Coupling, 12 Nm recalled?

Yes. Icotec Ag recalled Vader Pedicle System Torque Wrench, Hudson Coupling, 12 Nm on 3 Nov 2022. The recall is Class II and its status is Terminated. Recall number Z-0728-2023.

Why was it recalled?

Which lots are affected?

UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045

Where was it sold?

US Nationwide distribution in the state of GA.

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

More recalls from Icotec Ag

All 3

Reported	Class	Recall	Company	Reason	Where
17 Jan 2024Device	CLASS II	Vader pedicle system, torque wrench recalled by Icotec Ag	Icotec Ag	Device Malfunction	10 states
17 Jan 2024Device	CLASS II	Vader pedicle system, torque wrench recalled by Icotec Ag	Icotec Ag	Device Malfunction	10 states

Other Spinal Implants recalls

All 1,157

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide