Summary
The FDA issued a Class II for VADER pedicle system, torque wrench, Catalog Number 42-702 by Icotec Ag. Reason: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the devic.
Details
Source
Device Recall
External ID
Z-0700-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
VADER pedicle system, torque wrench, Catalog Number 42-702
Lot/Code Info: 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
Quantity Affected: 79 devices (US only)
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.
Distribution
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Altstatten Sg
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Icotec Ag has 11 FDA actions in our database, including 3 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Icotec Ag) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Icotec Ag have FDA actions?
Icotec Ag has 11 FDA actions in our database, including 3 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0700-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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