Recall Z-0291-2018— Orthofix Srl
Class II · Terminated
Class II FDA medical device recall by Orthofix Srl, initiated 2017-07-05, terminated 2023-01-13. It names 2 FDA 510(k) clearances: K153233, K142052. Product: Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.. Reason: The power drill torque limiter may break during use in surgery application..
- Recalling firm
- Orthofix Srl
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-05
- Terminated
- 2023-01-13
- Firm location
- Bussolengo, N/A, Italy
510(k) clearances named in this recall
2 on FDA's recordK-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
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Reason for recall
The power drill torque limiter may break during use in surgery application.
Data sourced from openFDA. This site is unofficial and independent of the FDA.