FDA-Device2015-10-21Class II
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Synthes (USA) Products LLC
Hazard
Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
Sold states
US Nationwide Distribution
Affected count
793
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2016Don'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