FDA-Device2015-09-02Class II
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Synthes (USA) Products LLC
Hazard
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Sold states
Nationwide and internationally to Canada.
Affected count
451
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2475-2015Don'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