Icotec recalls VADER Pedicle System Torque Wrench models with 12 Nm torque that may not limit torque properly, risking damage during use. Affected units have specific serial numbers and UDI/DI codes.
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.
Icotec is recalling VADER Pedicle System Torque Wrenches that may not properly limit torque, potentially causing damage to surgical equipment. This recall affects specific models sold with certain serial numbers.
During testing, the torque wrenches failed to limit torque to the specified 12 Nm level, instead measuring only 4 Nm. This could lead to improper tightening of surgical components, potentially causing equipment damage or safety issues during procedures.
Surgical professionals using the VADER Pedicle System Torque Wrenches with the specified serial numbers are most at risk. The recall applies to devices sold in the U.S. with the listed model and serial numbers.
Check for the serial numbers 200221-040 through 200221-045 or the UDI/DI code (01) 07640164844589 on the device. The product is labeled as VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702.
Look for serial numbers 200221-040 to 200221-045 on the VADER Pedicle System Torque Wrench.
The torque wrenches failed internal testing by measuring only 4 Nm instead of the specified 12 Nm torque limit, which could cause improper tightening of surgical components.
The recall record does not specify a remedy, so no action is required beyond checking if your device has the affected serial numbers.
Check for serial numbers 200221-040 through 200221-045 or the UDI/DI code (01) 07640164844589 on the VADER Pedicle System Torque Wrench.
We’ve drafted a message you can send Icotec to request your refund or repair — edit it as you like.
Subject: Recall Z-0728-2023 — Icotec Icotec Hello, I own a Icotec that is covered by recall Z-0728-2023 from Icotec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
