Summary
The FDA issued a Class II for VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 by Icotec Ag. Reason: During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specificatio.
Details
Source
Device Recall
External ID
Z-0728-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Lot/Code Info: UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Quantity Affected: 6 devices
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-03
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 404 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-0728-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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