Z-0701-2024Class II

VADER pedicle system, torque wrench, Catalog Number 42-703

Name: Z-0701-2024 VADER pedicle system, torque wrench, Catalog Number 42-703
Creator: Icotec Ag
Published: 2023-11-28
License: https://open.fda.gov/license/

Icotec AG / initiated 2023-11-28 / Open, Classified

FDA source

Icotec Ag began a recall of VADER pedicle system, torque wrench, Catalog Number 42-703 on 2023-11-28. FDA classified it as Class II and gives the reason as "icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0701-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-10
Recalling firm: Icotec AG
Product: VADER pedicle system, torque wrench, Catalog Number 42-703
Product code: PML Bone Cement, Posterior Screw Augmentation
Reason for recall: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
FDA root cause: Other
Action: icotec ag issued an URGENT Medical Device Recall notice to its consignees beginning on 11/28/2023 via email. The notice explained the problem with the device, the risk to health, and informed the medical facility that the affected product had been removed prior to the notice. Decision on whether patient-level follow-up is required should be made by the physician. Replacements will be provided where applicable. The firm expanded this recall on 12/27/2023 (notices delivered by US mail) to include additional lots and one additional product. Contact for questions: Laura Husken, [email protected], Tel.: +41 78 438 78 73
Distribution: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Product codes and lots: 220803-001, 220803-002, 220803-003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0701-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0700-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0701-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code PML

K222789Class IIVADER® Pedicle System, G21 CementIcotec AG / cleared 2023-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)