Reported Jan 17, 2024 · Ongoing
VADER pedicle system, torque wrench, Catalog Number 42-702
Icotec Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Icotec Ag · Industriestrasse 12 · Altstatten Sg · N/A
Is this the product you have?
- VADER pedicle system, torque wrench, Catalog Number 42-702
- Lot codes and dates
79 of 79 codes
19/01-00119/01-01319/01-01419/01-015190830-10190830-23190830-42190830-44190830-45190830-50190830-51190830-52200131-54200131-56200131-62200131-64200131-68200131-69200131-70200131-72200131-73200131-74200221-040R1200424-01200424-03200424-04200424-05200424-06200424-10200424-11200424-12200424-13200424-14200424-15200424-16200424-17200424-20200424-21200424-22200424-24200424-25200424-27200424-29200424-32200424-34200424-35200605-051R1200605-052R1201002-073R1210915-005210915-009210915-010210915-011210915-012220610-001220610-003220610-008220610-019220610-020220610-021
- Amount recalled
- 79 devices (US only)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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