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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93577

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 28, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Icotec Ag

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0700-2024
Recall number
Z-0700-2024
Initiated
November 28, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Icotec Ag
Quantity
79 devices (US only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

19/01-001, 19/01-013, 19/01-014, 19/01-015, 190830-10, 190830-23, 190830-42, 190830-44, 190830-45, 190830-50, 190830-51, 190830-52, 200131-54, 200131-56, 200131-62, 200131-64, 200131-68, 200131-69, 200131-70, 200131-72, 200131-73, 200131-74, 200221-040R1, 200424-01, 200424-03, 200424-04, 200424-05, 200424-06, 200424-10, 200424-11, 200424-12, 200424-13, 200424-14, 200424-15, 200424-16, 200424-17, 200424-20, 200424-21, 200424-22, 200424-24, 200424-25, 200424-27, 200424-29, 200424-32, 200424-34, 200424-35, 200605-051R1, 200605-052R1, 201002-073R1, 210915-005, 210915-009, 210915-010, 210915-011, 210915-012, 220610-001, 220610-003, 220610-008, 220610-019, 220610-020, 220610-021, 220610-025, 220610-026, 220610-030, 230113-003, 230113-005, 230113-007, 230113-008, 230113-009, 230113-010, 230113-011, 230113-012, 230113-013, 230113-014, 230224-029, 230224-034, 230426-038, 230426-039, 230426-042, 230426-043

Distribution pattern

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

device · product 2 of 2

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

Z-0701-2024
Recall number
Z-0701-2024
Initiated
November 28, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Icotec Ag
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

220803-001, 220803-002, 220803-003

Distribution pattern

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