Recall Z-0728-2023— Icotec Ag
Class II · Ongoing
Class II FDA medical device recall by Icotec Ag, initiated 2022-11-03. It names 3 FDA 510(k) clearances: K200596, K193423, K190545. Product: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702. Reason: 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..
- Recalling firm
- Icotec Ag
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-03
- Firm location
- Altstatten Sg, Switzerland
510(k) clearances named in this recall
3 on FDA's record- K200596 — G21 Cement, VADER® Pedicle System
- K193423 — VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
- K190545 — VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.