Dev4 Eleganz Fusion Screw System recalled for driver bit fracture risk
The driver bit included with the Dev4 Eleganz Fusion Screw System, 1.8mm (Cannulated), Short may fracture or break during use, which could cause an intraoperative delay. No injuries have been reported. The notice covers 34 units distributed nationwide, including in MN, IL, FL, TX, RI, CT, SC and NY.
From the FDA notice · Read the official notice ↗
What to do
- Check inventory for UDI-DI 00810190980682 with lot numbers 130601 or 106801, and set aside any affected units.
- The notice does not specify a remedy; contact Dev4 about the affected units and next steps.
- Use REF DI-2001 to identify the affected product when contacting Dev4.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Eleganz Fusion Screw System , 1.8mm (Cannulated), Short REF: DI-2001
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 34 units
- Illnesses reported
- None reported
- Manufactured in
- 1002 Gemini St Ste 129, Houston, Texas, United States
- Classification
- Class II
- Recall number
- Z-0411-2027
In the FDA's words
- Description
- Eleganz Fusion Screw System , 1.8mm (Cannulated), Short REF: DI-2001 Driver bit included in fusion Screw System may fracture or break during use resulting in intraoperative delay. UDI-DI 00810190980682/Lot Numbers 130601, 106801 Distribution: US Nationwide distribution in the states of MN, IL, FL, TX, RI, CT, SC, NY. Affected quantity: 34 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-2001 (this page)Z-0411-2027 · 34 units
- Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long
REF: DI-2004Z-0412-2027 · 27 units