FDA-Device2012-08-22Class II
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
Zimmer, Inc.
Hazard
Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
Sold states
Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
Affected count
24 to US Distributor with 7 further distributed
Manufactured in
345 E Main St, Warsaw, IN, United States
Products
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2187-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief