Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk
Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a device breaking during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Orthofix Srl is recalling 416 units of the Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use. The recall also includes specific kits containing the device, such as the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, and Galaxy UNYCO Ankle Bridging Boxes.
The recall was initiated because the power drill torque limiter may break during use in surgical applications. The device is intended for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
The affected units were distributed worldwide, including in the United States (California, Florida, and Pennsylvania) and in Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Orthofix Srl for further instructions.
The recalled product
- 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
- Manufacturer
- Orthofix Srl
- Affected units
- 416
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Power Drill Torque Limiter: Product Code 99-93568
- Lot (Exp Date) V1388296 (12/28/2019)
- V1388432 (12/29/2019)
- V1389857 (01/13/2020)
- V1400707 (05/18/2020)
- V1400940 (05/23/2020)
- V1410027 (09/01/2020)
- Lot (Exp Date) V1389818 (01/12/2020)
- V1389819 (01/12/2020)
- V1389886 (02/13/2020)
- V1399881 (05/10/2020)
- V1400800 (05/22/2020)
- V1402023 (06/03/2020)
- V1405602 (07/17/2020)
- V1406422 (07/26/2020)
- V1410082 (09/02/2020)
- R1412578 (09/28/2020)
- V1414451 (10/19/2020)
- V1421785 (02/01/2021)
- V1425406 (03/13/2021)
Distribution
Related recalls
Same manufacturer · Orthofix Srl
See all →- HighFitbone Trochanteric Nail may bend during insertion and require replacement
FDA (Devices) · 2025-06-25
- ModerateOrthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw
FDA (Devices) · 2019-11-20
- ModerateOrthofix Drill Bits Recalled for Geometrical Design Deviation
FDA (Devices) · 2019-11-20
Same hazard · device breakage
See all →- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01