Dev4 Eleganz Fusion drill driver bit recalled for fracture risk
Dev4 is recalling 27 units of the Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long. The driver bit included with the system may fracture or break during use, which could cause a delay during surgery. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside any units with UDI-DI 00810190980705 and lot number 103611 or 106802.
- Contact Dev4 about the affected units. The notice doesn't say how to get a replacement or refund, so ask Dev4 for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long REF: DI-2004
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 27 units
- Illnesses reported
- None reported
- Manufactured in
- 1002 Gemini St Ste 129, Houston, Texas, United States
- Classification
- Class II
- Recall number
- Z-0412-2027
In the FDA's words
- Description
- Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long REF: DI-2004 Driver bit included in fusion Screw System may fracture or break during use resulting in intraoperative delay. UDI-DI 00810190980705/Lot Numbers 103611, 106802 Distribution: US Nationwide distribution in the states of MN, IL, FL, TX, RI, CT, SC, NY. Affected quantity: 27 units
- Hazard
- Driver bit included in fusion Screw System may fracture or break during use resulting in intraoperative delay.
2 products in this recall
Eleganz Fusion Screw System recalled for possible driver bit fracture
Dev4 is recalling two Eleganz Fusion Screw System products: the 1.8mm cannulated short system (REF DI-2001) and the 1.8mm cannulated drill, long (REF DI-2004). The driver bit included with the screw system may fracture or break during use, which could cause a delay during surgery. No injuries have been reported. The products were distributed nationwide, including in MN, IL, FL, TX, RI, CT, SC and NY.
The agency lists each product separately. Check every one you might have.
- Eleganz Fusion Screw System , 1.8mm (Cannulated), Short
REF: DI-2001Z-0411-2027 · 34 units
- Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long
REF: DI-2004 (this page)Z-0412-2027 · 27 units