Icotec Ag recall records

2 reported ongoing

3 records in this archive. Latest source date Nov 28, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

VADER pedicle system, torque wrench, Catalog Number 42-702

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 ...

Class IIReported ongoing

Distribution: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA

Official source for VADER pedicle system, torque wrench, Catalog Number 42-702
FDA device enforcement

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

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 ...

Class IIReported ongoing

Distribution: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA

Official source for VADER pedicle system, torque wrench, Catalog Number 42-703
FDA device enforcement

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

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the state of GA.

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

Reasons in these listed records

  • 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 ...
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Icotec Ag

Is there a recall on icotec ag right now?

This archive contains 3 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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